Publications by authors named "James O Burton"

85 Publications

Aspirin for the primary prevention of cardiovascular disease in individuals with chronic kidney disease: a systematic review and meta-analysis.

Eur J Prev Cardiol 2021 Aug 27. Epub 2021 Aug 27.

John Walls Renal Unit, Leicester General Hospital, University Hospitals of Leicester, Leicester, UK.

Aims: Cardiovascular disease (CVD) is the major cause of morbidity and mortality in individuals with chronic kidney disease (CKD). This study assessed the risks and benefits of aspirin in the primary prevention of CVD in individuals with CKD.

Methods And Results: Ovid MEDLINE was searched from 2015 to 15th of September 2020 to include randomized controlled trials that assessed aspirin versus placebo in adults with non-end stage CKD without a previous diagnosis of CVD. A pre-specified protocol was registered with PROSPERO (identification number CRD42014008860). A random effects model was used to calculate a pooled hazard ratio (HR), pooled risk difference, and the number needed to treat or harm (NNT/NNH). The primary endpoint was CVD. Secondary endpoints included: all-cause mortality; coronary heart disease; stroke; and major and minor bleeding events. Five trials were identified (n = 7852 total, n = 3935 aspirin, n = 3917 placebo). Overall, 434 CVD events occurred. There was no statistically significant reduction in CVD events (HR 0.76, 95% confidence interval (CI) 0.54-1.08; P = 0.13, I2 = 63%), all-cause mortality (HR 0.94, 95% CI 0.74-1.19; P = 0.60, I2 = 21%), coronary heart disease events (HR 0.66, 95% CI 0.27-1.63; P = 0.37, I2 = 64%) or stroke (HR 0.87, 95% CI 0.6-1.27; P = 0.48, I2 = 24%) from aspirin therapy. The risk of major bleeding events were increased by approximately 50% (HR 1.53, 95% CI 1.13-2.05; P = 0.01, I2 = 0%) and minor bleeding events were more than doubled (HR 2.64, 95% CI 1.64-4.23; P < 0.01, I2 = 0%).

Conclusions: Aspirin cannot be routinely recommended for the primary prevention of CVD in individuals with CKD as there is no evidence for its benefit but there is an increased risk of bleeding.
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http://dx.doi.org/10.1093/eurjpc/zwab132DOI Listing
August 2021

A multicenter feasibility randomized controlled trial to assess the impact of incremental versus conventional initiation of hemodialysis on residual kidney function.

Kidney Int 2021 Aug 19. Epub 2021 Aug 19.

Renal Unit, Lister Hospital, East and North Hertfordshire National Health Service (NHS) Trust, Stevenage, UK; University of Hertfordshire, Hatfield, UK.

Twice-weekly hemodialysis, as part of incremental initiation, has reported benefits including preservation of residual kidney function (RKF). To explore this, we initiated a randomized controlled feasibility trial examining 55 incident hemodialysis patients with urea clearance of 3 ml/min/1.73 m or more across four centers in the United Kingdom randomized to standard or incremental schedules for 12 months. Incremental hemodialysis involved twice-weekly sessions, upwardly adjusting hemodialysis dose as RKF was lost, maintaining total (Dialysis+Renal) Std Kt/V above 2. Standard hemodialysis was thrice weekly for 3.5-4 hours, minimum Dialysis Std Kt/V of 2. Primary outcomes were feasibility parameters and effect size of group differences in rate of loss of RKF at six months. Health care cost impact and patient-reported outcomes were explored. Around one-third of patients met eligibility criteria. Half agreed to randomization; 26 received standard hemodialysis and 29 incremental. At 12 months, 21 incremental patients remained in the study vs 12 in the standard arm with no group differences in the urea clearance slope. Ninety-two percent of incremental and 75% of standard arm patients had a urea clearance of 2 ml/min/1.73 m or more at six months. Serious adverse events were less frequent in incremental patients (Incidence Rate Ratio 0.47, confidence interval 0.27-0.81). Serum bicarbonate was significantly lower in incremental patients indicating supplementation may be required. There were three deaths in each arm. Blood pressure, extracellular fluid and patient-reported outcomes were similar. There was no signal of benefit of incremental hemodialysis in terms of protection of RKF or Quality of Life score. Median incremental hemodialysis costs were significantly lower compared to standard hemodialysis. Thus, incremental hemodialysis appears safe and cost-saving in incident patients with adequate RKF, justifying a definitive trial.
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http://dx.doi.org/10.1016/j.kint.2021.07.025DOI Listing
August 2021

Measuring quality of life in trials including patients on dialysis: how are transplants and mortality incorporated into the analysis? A systematic review protocol.

BMJ Open 2021 08 18;11(8):e048179. Epub 2021 Aug 18.

Department of Health Sciences, University of Leicester, Leicester, UK.

Introduction: It is estimated that 25 000 people in the UK receive dialysis. Dialysis is an intrusive and time-consuming intervention that causes significant reductions in quality of life. When enrolled in a clinical trial, often some patients drop out of the study either because they die, receive a kidney transplant or are lost to follow-up for other reasons. It is unclear how these events are dealt with when analysing quality of life measures within clinical trials. This review will assess current practice for dealing with loss to follow-up in trials including patients on haemodialysis. The methods currently used will be analysed in terms of their adequacy and will form the basis of future work assessing the most appropriate methods to employ under these circumstances. The results of this review will feed into recommendations for future nephrology trials.

Methods And Analysis: A systematic search of electronic databases including MEDLINE and the Cochrane Library will be conducted to find clinical trials enrolling patients on haemodialysis that measure quality of life using either the kidney disease quality of life (KDQoL) or the short form 36 health survey (SF-36) (or any variation of these two measures). Ongoing trials will be identified through a search of trial registers. Articles will be screened against inclusion/exclusion criteria and data will be extracted using a predetermined data extraction form. General information such as the title, location, trial design will be extracted along with more specific information on how the study dealt with patients that died or received a transplant before the end of the follow-up period. Two independent reviewers will perform screening and extraction. Disagreements will be resolved by discussion or by a third independent reviewer. Data synthesis will be performed as a narrative summary.

Ethics And Dissemination: Ethics approval is not required. Dissemination will be by publication in a peer-reviewed journal.

Prospero Registration Number: CRD42020223869.
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http://dx.doi.org/10.1136/bmjopen-2020-048179DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8375767PMC
August 2021

Randomized Trial-PrEscription of intraDialytic exercise to improve quAlity of Life in Patients Receiving Hemodialysis.

Kidney Int Rep 2021 Aug 30;6(8):2159-2170. Epub 2021 May 30.

School of Health Sciences, Queen Margaret University, Edinburgh, UK.

Introduction: Whether clinically implementable exercise interventions in people receiving hemodialysis (HD) therapy improve health-related quality of life (HRQoL) remains unknown. The PrEscription of intraDialytic exercise to improve quAlity of Life PEDAL) study evaluated the clinical benefit and cost-effectiveness of a 6-month intradialytic exercise program.

Methods: In a multicenter, single-blinded, randomized, controlled trial, people receiving HD were randomly assigned to (i) intradialytic exercise training (exercise intervention group [EX]) and (ii) usual care (control group [CON]). Primary outcome was change in Kidney Disease Quality of Life Short-Form Physical Component Summary (KDQOL-SF 1.3 PCS) from baseline to 6 months. Cost-effectiveness was determined using health economic analysis; physiological impairment was evaluated by peak oxygen uptake; and harms were recorded.

Results: We randomized 379 participants; 335 and 243 patients (EX  = 127; CON  = 116) completed baseline and 6-month assessments, respectively. Mean difference in change PCS from baseline to 6 months between EX and CON was 2.4 (95% confidence interval [CI]: -0.1 to 4.8) arbitrary units ( = 0.055); no improvements were observed in peak oxygen uptake or secondary outcome measures. Participants in the intervention group had poor compliance (47%) and poor adherence (18%) to the exercise prescription. Cost of delivering intervention ranged from US$598 to US$1092 per participant per year. The number of participants with harms was similar between EX ( = 69) and CON ( = 56). A primary limitation was the lack of an attention CON. Many patients also withdrew from the study or were too unwell to complete all physiological outcome assessments.

Conclusions: A 6-month intradialytic aerobic exercise program was not clinically beneficial in improving HRQoL as delivered to this cohort of deconditioned patients on HD.
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http://dx.doi.org/10.1016/j.ekir.2021.05.034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8343798PMC
August 2021

Spinning the legs and blood: should intradialytic exercise be routinely offered during maintenance haemodialysis?

Clin Kidney J 2021 May 27;14(5):1297-1300. Epub 2021 Jan 27.

Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.

Patients with end-stage kidney disease on haemodialysis (HD) have an elevated risk of cardiovascular disease (CVD). These patients also experience high levels of physical deconditioning and programmes of rehabilitation have been tested in a variety of forms with variable success. It has been suggested that programmes of exercise rehabilitation have a role to play in improving the physical condition of patients on HD and in addressing the traditional and non-traditional risk factors that drive CVD for this population. Intradialytic exercise has often been suggested as a convenient way of delivering rehabilitation for patients on HD, as it makes use of otherwise dead time, but there are legitimate concerns about this group of at-risk patients undertaking exercise at a time when their myocardium is already vulnerable to the insults of demand ischaemia from the processes of dialysis and ultrafiltration. A study in this issue of provides reassuring data, showing that cycling during dialysis potentially reduces evidence of demand ischaemia (episodes of myocardial stunning). Together with the safety and quality of life data, we expect from the multicentre PrEscription of Intra-Dialytic Exercise to Improve quAlity of Life in Patients With Chronic Kidney Disease study (the protocol for which is published concurrently), rehabilitation programmes that include intradialytic exercise are perhaps closer than ever for patients on HD.
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http://dx.doi.org/10.1093/ckj/sfab018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247751PMC
May 2021

A Cost-Effective Analysis of the CYCLE-HD Randomized Controlled Trial.

Kidney Int Rep 2021 Jun 8;6(6):1548-1557. Epub 2021 Apr 8.

Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.

Introduction: No formal cost-effectiveness analysis has been performed for programs of cycling exercise during dialysis (intradialytic cycling [IDC]). The objective of this analysis is to determine the effect of a 6-month program of IDC on health care costs.

Methods: This is a retrospective formal cost-effectiveness analysis of adult participants with end-stage kidney disease undertaking in-center maintenance hemodialysis enrolled in the CYCLE-HD trial. Data on hospital utilization, primary care consultations, and prescribed medications were extracted from medical records for the 6 months before, during, and after a 6-month program of thrice-weekly IDC. The cost-effectiveness analysis was conducted from a health care service perspective and included the cost of implementing the IDC intervention. The base-case analyses included a 6-month "within trial" analysis and a 12-month "within and posttrial" analysis considering health care utilization and quality of life (QoL) outcomes.

Results: Data from the base-case within trial analysis, based on 109 participants ( = 56 control subjects and  = 53 IDC subjects) showed a reduction in health care utilization costs between groups, favoring the IDC group, and a 73% chance of IDC being cost-effective compared with control subjects at a willingness to pay of £20,000 and £30,000 per quality-adjusted life year (QALY) gained. When QoL data points were extrapolated forward to 12 months, the probability of IDC being cost-effective was 93% and 94% at £20,000 and £30,000 per QALY gained. Sensitivity analysis broadly confirms these findings.

Conclusion: A 6-month program of IDC is cost-effective and the implementation of these programs nationally should be a priority.
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http://dx.doi.org/10.1016/j.ekir.2021.02.036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8207470PMC
June 2021

Exercise programme to improve quality of life for patients with end-stage kidney disease receiving haemodialysis: the PEDAL RCT.

Health Technol Assess 2021 Jun;25(40):1-52

School of Health Sciences, Queen Margaret University, Edinburgh, UK.

Background: Whether or not clinically implementable exercise interventions in haemodialysis patients improve quality of life remains unknown.

Objectives: The PEDAL (PrEscription of intraDialytic exercise to improve quAlity of Life in patients with chronic kidney disease) trial evaluated the clinical effectiveness and cost-effectiveness of a 6-month intradialytic exercise programme on quality of life compared with usual care for haemodialysis patients.

Design: We conducted a prospective, multicentre randomised controlled trial of haemodialysis patients from five haemodialysis centres in the UK and randomly assigned them (1 : 1) using a web-based system to (1) intradialytic exercise training plus usual-care maintenance haemodialysis or (2) usual-care maintenance haemodialysis.

Setting: The setting was five dialysis units across the UK from 2015 to 2019.

Participants: The participants were adult patients with end-stage kidney disease who had been receiving haemodialysis therapy for > 1 year.

Interventions: Participants were randomised to receive usual-care maintenance haemodialysis or usual-care maintenance haemodialysis plus intradialytic exercise training.

Main Outcome Measures: The primary outcome of the study was change in Kidney Disease Quality of Life Short Form, version 1.3, physical component summary score (from baseline to 6 months). Cost-effectiveness was determined using health economic analysis and the EuroQol-5 Dimensions, five-level version. Additional secondary outcomes included quality of life (Kidney Disease Quality of Life Short Form, version 1.3, generic multi-item and burden of kidney disease scales), functional capacity (sit-to-stand 60 and 10-metre Timed Up and Go tests), physiological measures (peak oxygen uptake and arterial stiffness), habitual physical activity levels (measured by the International Physical Activity Questionnaire and Duke Activity Status Index), fear of falling (measured by the Tinetti Falls Efficacy Scale), anthropometric measures (body mass index and waist circumference), clinical measures (including medication use, resting blood pressure, routine biochemistry, hospitalisations) and harms associated with intervention. A nested qualitative study was conducted.

Results: We randomised 379 participants; 335 patients completed baseline assessments and 243 patients (intervention,  = 127; control,  = 116) completed 6-month assessments. The mean difference in change in physical component summary score from baseline to 6 months between the intervention group and control group was 2.4 arbitrary units (95% confidence interval -0.1 to 4.8 arbitrary units;  = 0.055). Participants in the intervention group had poor compliance (49%) and very poor adherence (18%) to the exercise prescription. The cost of delivering the intervention ranged from £463 to £848 per participant per year. The number of participants with harms was similar in the intervention ( = 69) and control ( = 56) groups.

Limitations: Participants could not be blinded to the intervention; however, outcome assessors were blinded to group allocation.

Conclusions: On trial completion the primary outcome (Kidney Disease Quality of Life Short Form, version 1.3, physical component summary score) was not statistically improved compared with usual care. The findings suggest that implementation of an intradialytic cycling programme is not an effective intervention to enhance health-related quality of life, as delivered to this cohort of deconditioned patients receiving haemodialysis.

Future Work: The benefits of longer interventions, including progressive resistance training, should be confirmed even if extradialytic delivery is required. Future studies also need to evaluate whether or not there are subgroups of patients who may benefit from this type of intervention, and whether or not there is scope to optimise the exercise intervention to improve compliance and clinical effectiveness.

Trial Registration: Current Controlled Trials ISRCTN83508514.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 40. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25400DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256322PMC
June 2021

Evaluating the clinical experience of a regional in-center nocturnal hemodialysis program: The patient and staff perspective.

Hemodial Int 2021 Jun 16. Epub 2021 Jun 16.

Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.

Introduction: End-stage kidney disease causes significant morbidity, mortality, and reduced quality of life. Despite improvements in conventional hemodialysis, these problems persist. In-center nocturnal hemodialysis (INHD) has been shown to be beneficial in observational studies. This report outlines a 4-year renal network experience of INHD from the patient and frontline staff perspective.

Methods: Staff and patients' experiences of INHD were evaluated through two work streams. Work stream one: 12 patients who chose to stop INHD and 24 patients who chose to continue with INHD completed an anonymous survey. Work stream two: one-to-one interviews with 20 patients receiving INHD and seven staff working INHD shifts were conducted. Clinical incident reporting for conventional hemodialysis and INHD from April 2014 to December 2018 was reviewed.

Findings: Work stream one: Five themes were identified; facilities, time, health and well-being, sleep, and transport. A patient "starter pack" was developed and improvements to the dialysis unit were completed. Work stream two: Patient interviews demonstrated starter packs to aid sleep were well received; sleep itself was not a single reason to discontinue INHD. Staff indicated that their greatest concern was staffing levels; although staff-to-patient ratio remains unchanged, total numbers on INHD shifts were fewer, causing concern around less colleague availability for support during an emergency.

Safety: 363 clinical incidents were reported across all dialysis shifts; for conventional hemodialysis, a larger proportion were due to medical interventions, infection control, and transport; for INHD, most incidents centered around communication with patients and relatives, delays in patient transfer, and issues with medical equipment or facilities.

Discussion: Patients continue with INHD due to increased social time and perceived health benefits. Patient starter packs and adjustments to the dialysis unit may enhance sleep. This experience has optimized the design of the NightLife study; a randomized controlled trial evaluated the effect of INHD on quality of life.
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http://dx.doi.org/10.1111/hdi.12953DOI Listing
June 2021

A randomized controlled trial to investigate the effects of intra-dialytic cycling on left ventricular mass.

Kidney Int 2021 06 8;99(6):1478-1486. Epub 2021 Apr 8.

Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; National Institute of Health Research Leicester Biomedical Research Centre, University of Leicester, Leicester, UK; National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health, Loughborough University, Loughborough, UK. Electronic address:

Cardiovascular disease is the leading cause of death for patients receiving hemodialysis. Since exercise mitigates many risk factors which drive cardiovascular disease for these patients, we assessed effects of a program of intra-dialytic cycling on left ventricular mass and other prognostically relevant measures of cardiovascular disease as evaluated by cardiac MRI (the CYCLE-HD trial). This was a prospective, open-label, single-blinded cluster-randomized controlled trial powered to detect a 15g difference in left ventricular mass measured between patients undergoing a six-month program of intra-dialytic cycling (exercise group) and patients continuing usual care (control group). Pre-specified secondary outcomes included measures of myocardial fibrosis, aortic stiffness, physical functioning, quality of life and ventricular arrhythmias. Outcomes were analyzed as intention-to-treat according to a pre-specified statistical analysis plan. Initially, 130 individuals were recruited and completed baseline assessments (65 each group). Ultimately, 101 patients completed the trial protocol (50 control group and 51 exercise group). The six-month program of intra-dialytic cycling resulted in a significant reduction in left ventricular mass between groups (-11.1g; 95% confidence interval -15.79, -6.43), which remained significant on sensitivity analysis (missing data imputed) (-9.92g; 14.68, -5.16). There were significant reductions in both native T1 mapping and aortic pulse wave velocity between groups favoring the intervention. There was no increase in either ventricular ectopic beats or complex ventricular arrhythmias as a result of exercise with no significant effect on physical function or quality of life. Thus, a six-month program of intradialytic cycling reduces left ventricular mass and is safe, deliverable and well tolerated.
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http://dx.doi.org/10.1016/j.kint.2021.02.027DOI Listing
June 2021

Circulating endotoxin and inflammation: associations with fitness, physical activity and the effect of a six-month programme of cycling exercise during haemodialysis.

Nephrol Dial Transplant 2021 May 13. Epub 2021 May 13.

Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.

Background: Intradialytic cycling (IDC) may provide cardiovascular benefit to individuals receiving haemodialysis, but the exact mechanism behind these improvements remains unclear. The primary aim of this study was to investigate the effect of a six-month programme of IDC on circulating endotoxin (secondary analysis from the CYCLE-HD trial). Secondary aims were to investigate changes in circulating cytokines (IL-6, IL-10, TNF-α, CRP and IL6/IL-10), and their associations with physical activity, fitness and cardiovascular outcomes.

Methods: Participants were randomised to either a six-month programme of IDC (thrice weekly, moderate intensity cycling at RPE 12-14) in addition to usual care (n = 46), or usual care only (control group; n = 46). Outcome measures were obtained at baseline and then again at six months.

Results: There was no significant (P=0.137) difference in circulating endotoxin between groups at 6-months (IDC group: 0.34±0.08 EU/mL; control group: 0.37±0.07 EU/mL). There were no significant between group difference in any circulating cytokine following the 6-month programme of IDC. Higher levels of physical activity and fitness were associated with lower levels of endotoxin, IL-6, CRP, and IL-6/IL-10.

Conclusions: Our data show no change in circulating endotoxin or cytokines following a 6-month programme of IDC. However, higher levels of physical activity outside of haemodialysis were associated with lower levels of inflammation.
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http://dx.doi.org/10.1093/ndt/gfab178DOI Listing
May 2021

Differences in native T1 and native T2 mapping between patients on hemodialysis and control subjects.

Eur J Radiol 2021 Jul 1;140:109748. Epub 2021 May 1.

Department of Cardiovascular Sciences, University of Leicester and Cardiovascular Theme, NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, United Kingdom.

Purpose: Myocardial native T1 is a potential measure of myocardial fibrosis, but concerns remain over the potential influence of myocardial edema to increased native T1 signal in subjects prone to fluid overload. This study describes differences in native T2 (typically raised in states of myocardial edema) and native T1 times in patients on hemodialysis by comparing native T1 and native T2 times between subjects on hemodialysis to an asymptomatic control group. Reproducibility of these sequences was tested.

Methods: Subjects were recruited prospectively and underwent 3 T-cardiac MRI with acquisition of native T1 and native T2 maps. Between group differences in native T1 and T2 maps were assessed using one-way ANOVAs. 30 subjects underwent test-retest scans within a week of their original scan to define sequence reproducibility.

Results: 261 subjects completed the study (hemodialysis n = 124, control n = 137). Native T1 times were significantly increased in subjects on hemodialysis compared to control subjects (1259 ms ± 51 vs 1212 ms ± 37, p < 0.01). There was no difference in native T2 times between subjects on hemodialysis and control subjects (39.5 ms ± 2.5 vs 39.5 ms ± 2.3, p = 0.9). These differences were unchanged after adjustment for relevant baseline differences (age, sex and hemoglobin). Inter-study reproducibility for native T1 and T2 mapping was excellent (coefficient of variability 0.9 % and 2.6 % respectively).

Conclusions: The increased native T1 signal demonstrated in subjects on hemodialysis occurs independently of differences in native T2 and the two parameters are not orthogonal. Elevated native T1 in patients on hemodialysis may be driven by water related to myocardial fibrosis rather than edema from volume overload.
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http://dx.doi.org/10.1016/j.ejrad.2021.109748DOI Listing
July 2021

A Comparison of Dietary Intake Between Individuals Undergoing Maintenance Hemodialysis in the United Kingdom and China.

J Ren Nutr 2021 Apr 19. Epub 2021 Apr 19.

Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom; NIHR Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust, Leicester, UK; School of Sport, Exercise & Health Sciences, Loughborough University, United Kingdom.

Objective: Protein-energy wasting is highly prevalent in people with end-stage kidney disease receiving regular hemodialysis. Currently, it is unclear what the optimal nutritional recommendations are, which is further complicated by differences in dietary patterns between countries. The aim of the study was to understand and compare dietary intake between individuals receiving hemodialysis in Leicester, UK and Nantong, China.

Methods: The study assessed 40 UK and 44 Chinese participants' dietary intake over a period of 14 days using 24-hour diet recall interviews. Nutritional blood parameters were obtained from medical records. Food consumed by participants in the UK and China was analyzed using the Nutritics and Nutrition calculator to quantify nutritional intake.

Results: Energy and protein intake were comparable between UK and Chinese participants, but with both below the recommended daily intake. Potassium intake was higher in UK participants compared to Chinese participants (2,115 [888] versus 1,159 [861] mg/d; P < .001), as was calcium (618 [257] versus 360 [312] mg/d; P < .001) and phosphate intake (927 [485] versus 697 [434] mg/d; P = .007). Vitamin C intake was lower in UK participants compared to their Chinese counterparts (39 [51] versus 64 [42] mg/d; P = .024). Data are reported here as median (interquartile range).

Conclusion: Both UK and Chinese hemodialysis participants have insufficient protein and energy in their diet. New strategies are required to increase protein and energy intakes. All participants had inadequate daily intake of vitamins C and D; there may well be a role in the oral supplementation of these vitamins, and further studies are urgently needed.
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http://dx.doi.org/10.1053/j.jrn.2021.03.003DOI Listing
April 2021

Seroprevalence of antibody to S1 spike protein following vaccination against COVID-19 in patients receiving hemodialysis: a call to arms.

Kidney Int 2021 06 20;99(6):1492-1494. Epub 2021 Apr 20.

Department of Cardiovascular Sciences, University of Leicester and National Institute for Health Research Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital Leicester, Leicester, UK; John Walls Renal Unit, University Hospitals Leicester National Health Service Trust, Leicester, UK; National Institute for Health Research Leicester Biomedical Research Centre, University Hospitals of Leicester National Health Service Trust, Leicester, UK. Electronic address:

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http://dx.doi.org/10.1016/j.kint.2021.04.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8055918PMC
June 2021

A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas.

Kidney Int 2021 08 27;100(2):447-456. Epub 2021 Mar 27.

Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Nephrology and Transplantation, Guy's and St Thomas' NHS Foundation Trust, London, UK. Electronic address:

The role of paclitaxel-coated balloons has been established in the coronary and peripheral arterial circulations with recent interest in the use of paclitaxel-coated balloons to improve patency rates following angioplasty of arteriovenous fistulas. To assess the efficacy of paclitaxel-coated angioplasty balloons to prolong the survival time of target lesion primary patency in arteriovenous fistulas, we designed an investigator-led multi-center randomized controlled trial with follow up time variable for a minimum of one year. Patients with an arteriovenous fistula who were undergoing an angioplasty for a clinical indication were included but patients with one or more lesions outside the treatment segment were excluded. Following successful treatment with a high-pressure balloon, 212 patients were randomized. In the intervention arm, the second component was insertion of a paclitaxel-coated balloon. In the control arm, an identical procedure was followed, but using a standard balloon. The primary endpoint was time to loss of clinically driven target lesion primary patency. Primary analysis showed no significant evidence for a difference in time to end of target lesion primary patency between groups: hazard ratio 1.18 with a 95% confidence interval of 0.78 to 1.79. There were no significant differences for any secondary outcomes, including patency outcomes and adverse events. Thus, our study demonstrated no evidence that paclitaxel-coated balloons provide benefit, following standard care high-pressure balloon angioplasty, in the treatment of arteriovenous fistulas. Hence, in view of the benefit suggested by other trials, the role of paclitaxel-coated angioplasty balloons remains uncertain.
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http://dx.doi.org/10.1016/j.kint.2021.02.040DOI Listing
August 2021

Perceptions of exercise benefits and barriers: the influence on physical activity behaviour in individuals undergoing haemodialysis and peritoneal dialysis.

J Nephrol 2021 Mar 26. Epub 2021 Mar 26.

Leicester Kidney Lifestyle Team, Department of Health Sciences, University of Leicester, Leicester, LE17RH, UK.

Background: Despite growing evidence about the benefits of physical activity and exercise in patients receiving dialysis, physical inactivity is highly prevalent. This may be due to uncertainty and lack of appropriate guidance about exercise, or driven by the relative barriers and benefits that patients perceive. Understanding these perceptions in dialysis patients may inform interventions aimed to increase exercise participation.

Methods: Perceived benefits and barriers to exercise were measured by the 'Dialysis Patient-perceived Exercise Benefits and Barriers Scale' (DPEBBS). Self-reported physical activity status was assessed by the 'General Practice Physical Activity Questionnaire'. Barriers and benefits to exercise were classed as binary variables (i.e. yes and no). Frequency analyses and chi-squared tests were conducted to compare the differences perceived by people on haemodialysis (HD) and peritoneal dialysis (PD). Binominal logistical regression was performed to determine which perceived barriers and benefits had the biggest impact on physical activity status.

Results: One thousand twenty-two HD and 124 PD patients completed the DPEBBS. A greater proportion of HD than PD patients reported 'reduces body pain' (P = 0.013), 'delays decline in body function' (P = 0.01), and 'improves quality of life' (P = 0.033) as benefits of exercise. No differences in barriers were observed. Tiredness was the most reported barrier to exercise. Patients who perceived 'other comorbidities' (OR 3.389, P < 0.001) or 'burden of family' (OR 3.168, P < 0.001) as barriers were 3 times more likely to be inactive.

Conclusions: Dialysis patients perceive several barriers which may prevent them from engaging in physical activity. Addressing these barriers may be key to increasing participation in physical activity and exercise.
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http://dx.doi.org/10.1007/s40620-021-01024-yDOI Listing
March 2021

Resolution of warfarin-induced alopecia with conversion to apixaban.

BMJ Case Rep 2021 Mar 2;14(3). Epub 2021 Mar 2.

Cardiovascular Sciences, University of Leicester, Leicester, UK.

Warfarin is frequently prescribed as a long-term anticoagulant in patients with end-stage kidney disease as direct oral anticoagulants undergo renal excretion. Anticoagulation is a rare cause of alopecia in adults and is thought to be due to the promotion of the 'resting phase' of hair follicles. In this case report, a prevalent haemodialysis female patient required long-term anticoagulation following a complex pulmonary embolus and dialysis access complications. After commencing warfarin therapy, the patient reported generalised loss and thinning of her hair. All other potential causes were excluded. Cessation of warfarin therapy and conversion to apixaban with close monitoring alleviated the hair loss. Warfarin therapy is a rare cause of alopecia but should be considered in patients on long-term anticoagulation when other diagnoses have been excluded. Hair loss has a profoundly negative impact on patient quality of life and should prompt investigation to determine the underlying cause.
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http://dx.doi.org/10.1136/bcr-2020-240579DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7929877PMC
March 2021

"To take or not to take an aspirin?" The age-old question of cardiovascular disease primary prevention for people with chronic kidney disease.

Kidney Int 2021 02;99(2):308-310

John Walls Renal Unit, University Hospitals of Leicester, Leicester General Hospital, Leicester, UK; Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.

Despite the higher risk of cardiovascular events in patients with chronic kidney disease, the role of aspirin for primary prevention is unclear. In the current issue, Wolfe et al. present a subgroup analysis of the ASPirin in Reducing Events in the Elderly (ASPREE) trial that suggests there was no reduction in cardiovascular events but bleeding events were doubled. Aspirin cannot be recommended for primary prevention in chronic kidney disease, but the continuation of ongoing research, such as the Aspirin To Target Arterial Events in Chronic Kidney Disease (ATTACK trial), is warranted.
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http://dx.doi.org/10.1016/j.kint.2020.09.008DOI Listing
February 2021

Recent advances in treatment of haemodialysis.

J R Soc Med 2021 01 3;114(1):30-37. Epub 2020 Dec 3.

Department of Nephrology, Colchester General Hospital, East Suffolk and North Essex NHS Foundation Trust, Colchester CO4 5JL, UK.

Haemodialysis remains the most widely used treatment for patients with end-stage renal disease. Despite the progress that has occurred in the treatment of end-stage renal disease over the last six decades, there has been a failure to translate this into the desired clinical benefits, with morbidity and mortality rates among patients on haemodialysis remaining unacceptably high. Recently, however, there have been expectations that the significant advances that took place over the last few years may result in improved outcomes. New medications for the treatment of anaemia and secondary hyperparathyroidism, as well as novel trends in the areas of iron therapy, diabetes management and physical exercise are among the most important advances which, taken together, are changing the standards of care for patients on haemodialysis. The latest advances, of relevance not only to specialists in Renal Medicine but also to general practitioners caring for these patients, are reviewed in this collaborative paper.
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http://dx.doi.org/10.1177/0141076820972669DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8173362PMC
January 2021

The cardiovascular determinants of physical function in patients with end-stage kidney disease on haemodialysis.

Int J Cardiovasc Imaging 2021 Apr 30;37(4):1405-1414. Epub 2020 Nov 30.

Department of Cardiovascular Sciences, University of Leicester and NIHR Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, UK.

Patients with end-stage kidney disease (ESKD) are often sedentary and decreased functional capacity associates with mortality. The relationship between cardiovascular disease (CVD) and physical function has not been fully explored. Understanding the relationships between prognostically relevant measures of CVD and physical function may offer insight into how exercise interventions might target specific elements of CVD. 130 patients on haemodialysis (mean age 57 ± 15 years, 73% male, dialysis vintage 1.3 years (0.5, 3.4), recruited to the CYCLE-HD trial (ISRCTN11299707), underwent cardiovascular phenotyping with cardiac MRI (left ventricular (LV) structure and function, pulse wave velocity (PWV) and native T1 mapping) and cardiac biomarker assessment. Participants completed the incremental shuttle walk test (ISWT) and sit-to-stand 60 (STS60) as field-tests of physical function. Linear regression models identified CV determinants of physical function measures, adjusted for age, gender, BMI, diabetes, ethnicity and systolic blood pressure. Troponin I, PWV and global native T1 were univariate determinants of ISWT and STS60 performance. NT pro-BNP was a univariate determinant of ISWT performance. In multivariate models, NT pro-BNP and global native T1 were independent determinants of ISWT and STS60 performance. LV ejection fraction was an independent determinant of ISWT distance. However, age and diabetes had the strongest relationships with physical function. In conclusion, NT pro-BNP, global native T1 and LV ejection fraction were independent CV determinants of physical function. However, age and diabetes had the greatest independent influence. Targeting diabetic care may ameliorate deconditioning in these patients and a multimorbidity approach should be considered when developing exercise interventions.
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http://dx.doi.org/10.1007/s10554-020-02112-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8026413PMC
April 2021

Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study.

BMJ Open 2020 11 3;10(11):e041227. Epub 2020 Nov 3.

Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.

Objectives: Frailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.

Design: Mixed-methods feasibility.

Setting And Participants: Prevalent adult HD patients of the trial with a Clinical Frailty Scale Score of 4-7 (vulnerable to severely frail) were eligible for the feasibility study.

Interventions: Participants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).

Outcomes: Primary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.

Results: 124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%-89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.

Conclusions: A definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.

Trial Registration Numbers: ISRCTN11299707; ISRCTN12840463.
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http://dx.doi.org/10.1136/bmjopen-2020-041227DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640592PMC
November 2020

Hyperphosphatemia Drives Procoagulant Microvesicle Generation in the Rat Partial Nephrectomy Model of CKD.

J Clin Med 2020 Nov 1;9(11). Epub 2020 Nov 1.

Department of Cardiovascular Sciences, University of Leicester, and Leicester NIHR Cardiovascular Biomedical Research Unit, Leicester LE3 9QP, UK.

Hyperphosphatemia has been proposed as a cardiovascular risk factor, contributing to long-term vascular calcification in hyperphosphatemic Chronic Kidney Disease (CKD) patients. However, more recent studies have also demonstrated acute effects of inorganic phosphate (Pi) on endothelial cells in vitro, especially generation of pro-coagulant endothelial microvesicles (MV). Hitherto, such direct effects of hyperphosphatemia have not been reported in vivo. Thirty-six male Sprague-Dawley rats were randomly allocated to three experimental groups: (1) CKD induced by partial nephrectomy receiving high (1.2%) dietary phosphorus; (2) CKD receiving low (0.2%) dietary phosphorus; and (3) sham-operated controls receiving 1.2% phosphorus. After 14 days the animals were sacrificed and plasma MVs counted by nanoparticle tracking analysis. MVs isolated by centrifugation were assayed for pro-coagulant activity by calibrated automated thrombography, and relative content of endothelium-derived MVs was assessed by anti-CD144 immunoblotting. When compared with sham controls, high phosphorus CKD rats were shown to be hyperphosphatemic (4.11 ± 0.23 versus 2.41 ± 0.22 mM Pi, < 0.0001) with elevated total plasma MVs (2.24 ± 0.37 versus 1.31 ± 0.24 × 10 per ml, < 0.01), showing increased CD144 expression (145 ± 25% of control value, < 0.0001), and enhanced procoagulant activity (18.06 ± 1.75 versus 4.99 ± 1.77 nM peak thrombin, < 0.0001). These effects were abolished in the low phosphorus CKD group. In this rat model, hyperphosphatemia (or a Pi-dependent hormonal response derived from it) is sufficient to induce a marked increase in circulating pro-coagulant MVs, demonstrating an important link between hyperphosphatemia and thrombotic risk in CKD.
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http://dx.doi.org/10.3390/jcm9113534DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7692968PMC
November 2020

Exercise as a therapeutic option for acute kidney injury: mechanisms and considerations for the design of future clinical studies.

BMC Nephrol 2020 10 23;21(1):446. Epub 2020 Oct 23.

Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.

Acute kidney injury (AKI) is a known risk factor for chronic kidney disease (CKD) and end stage kidney disease (ESKD). The progression from AKI to CKD, despite being well recognised, is not completely understood, although sustained inflammation and fibrosis are implicated. A therapeutic intervention targeting the post AKI stage could reduce the progression to CKD, which has high levels of associated morbidity and mortality. Exercise has known anti-inflammatory effects with animal AKI models demonstrating its use as a therapeutic agent in abrogating renal injury. This suggests the use of an exercise rehabilitation programme in AKI patients following discharge could attenuate renal damage and improve long term patient outcomes. In this review article we outline considerations for future clinical studies of exercise in the AKI population.
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http://dx.doi.org/10.1186/s12882-020-02098-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7585193PMC
October 2020

Inorganic Phosphate (Pi) Signaling in Endothelial Cells: A Molecular Basis for Generation of Endothelial Microvesicles in Uraemic Cardiovascular Disease.

Int J Mol Sci 2020 Sep 23;21(19). Epub 2020 Sep 23.

Department of Cardiovascular Sciences, University of Leicester, and Leicester NIHR Cardiovascular Biomedical Research Unit, Leicester LE3 9QP, UK.

Hyperphosphataemia increases cardiovascular mortality in patients with kidney disease. Direct effects of high inorganic phosphate (Pi) concentrations have previously been demonstrated on endothelial cells (ECs), including generation of procoagulant endothelial microvesicles (MVs). However, no mechanism directly sensing elevated intracellular Pi has ever been described in mammalian cells. Here, we investigated the hypothesis that direct inhibition by Pi of the phosphoprotein phosphatase PP2A fulfils this sensing role in ECs, culminating in cytoskeleton disruption and MV generation. ECs were treated with control (1 mM [Pi]) vs. high (2.5 mM [Pi]), a condition that drives actin stress fibre depletion and MV generation demonstrated by confocal microscopy of F-actin and NanoSight Nanoparticle tracking, respectively. Immuno-blotting demonstrated that high Pi increased p-Src, p-PP2A-C and p-DAPK-1 and decreased p-TPM-3. Pi at 100 μM directly inhibited PP2A catalytic activity. Inhibition of PP2A enhanced inhibitory phosphorylation of DAPK-1, leading to hypophosphorylation of Tropomyosin-3 at S284 and MV generation. p-Src is known to perform inhibitory phosphorylation on DAPK-1 but also on PP2A-C. However, PP2A-C can itself dephosphorylate (and therefore inhibit) p-Src. The direct inhibition of PP2A-C by Pi is, therefore, amplified by the feedback loop between PP2A-C and p-Src, resulting in further PP2A-C inhibition. These data demonstrated that PP2A/Src acts as a potent sensor and amplifier of Pi signals which can further signal through DAPK-1/Tropomyosin-3 to generate cytoskeleton disruption and generation of potentially pathological MVs.
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http://dx.doi.org/10.3390/ijms21196993DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7583816PMC
September 2020

The reliability and feasibility of non-contrast adenosine stress cardiovascular magnetic resonance T1 mapping in patients on haemodialysis.

J Cardiovasc Magn Reson 2020 06 8;22(1):43. Epub 2020 Jun 8.

Department of Cardiovascular Sciences, University of Leicester and the NIHR Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, LE1 9HN, UK.

Background: Identifying coronary artery disease (CAD) in patients with end-stage renal disease (ESRD) is challenging. Adenosine stress native T1 mapping with cardiovascular magnetic resonance (CMR) may accurately detect obstructive CAD and microvascular dysfunction in the general population. This study assessed the feasibility and reliability of adenosine stress native T1 mapping in patients on haemodialysis.

Methods: The feasibility of undertaking rest and adenosine stress native T1 mapping using the single-shot Modified Look-Locker inversion recovery (MOLLI) sequence was assessed in 58 patients on maintenance haemodialysis using 3 T CMR. Ten patients underwent repeat stress CMR within 2 weeks for assessment of test-retest reliability of native T1, stress T1 and delta T1 (ΔT1). Interrater and intrarater agreement were assessed in 10 patients. Exploratory analyses were undertaken to assess associations between clinical variables and native T1 values in 51 patients on haemodialysis.

Results: Mean age of participants was 55 ± 15 years, 46 (79%) were male, and median dialysis vintage was 21 (8; 48) months. All patients completed the scan without complications. Mean native T1 rest, stress and ΔT1 were 1261 ± 57 ms, 1297 ± 50 ms and 2.9 ± 2.5%, respectively. Interrater and intrarater agreement of rest T1, stress T1 and ΔT1 were excellent, with intraclass correlation coefficients (ICC) > 0.9 for all. Test-retest reliability of rest and stress native T1 were excellent or good (CoV 1.2 and 1.5%; ICC, 0.79 and 0.69, respectively). Test-retest reliability of ΔT1 was moderate to poor (CoV 27.4%, ICC 0.55). On multivariate analysis, CAD, diabetes mellitus and resting native T1 time were independent determinants of ΔT1 (β = - 0.275, p = 0.019; β = - 0.297, p = 0.013; β = - 0.455; p < 0.001, respectively).

Conclusions: Rest and adenosine stress native T1 mapping is feasible and well-tolerated amongst patients with ESRD on haemodialysis. Although rater agreement of the technique is excellent, test-retest reliability of ΔT1 is moderate to poor. Prospective studies should evaluate the relationship between this technique and established methods of CAD assessment and association with outcomes.
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http://dx.doi.org/10.1186/s12968-020-00634-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7278072PMC
June 2020

Conversion of haemodialysis patients from iron sucrose to iron isomaltoside: a real-world experience.

BMC Nephrol 2020 06 3;21(1):212. Epub 2020 Jun 3.

Hull University Teaching Hospitals NHS Trust and Hull York Medical School, Hull, UK.

Background: Anaemia is common in haemodialysis (HD) patients and associated with significant morbidity and mortality. Intravenous (IV) iron combined with erythropoiesis-stimulating agents (ESA) is the mainstay treatment of anaemia in these patients. The comparative efficacy and risk of adverse events with IV iron preparations have been assessed in only a few trials.

Methods: This was a retrospective observational study in 2 centres designed to compare the safety and efficacy of iron sucrose (IS-Venofer®) versus iron isomaltoside (IIM-Diafer®) in haemodialysis patients. The study included patients currently on dialysis and receiving Venofer who were switched to Diafer® and monitored for at least 12 months for each iron preparation.

Results: A total of 190 patients were included and had a mean age of 65.8 years (SD ± 15.5). Non-inferiority was confirmed with no change in mean haemoglobin per mg of iron administered over a 12-month period. In total there were 41,295 prescriptions of iron isomaltoside and 14,685 of iron sucrose with no difference in the number of reported adverse events during the study period (7 each, none were severe). There was a statistically significant effect on Hb over time after conversion, including adjustment for multiple comparisons. There were significant improvements in ferritin over time, which remained at 6 months (P < 0.01). The weekly iron dose was similar after adjustment (P = 0.02). The EPO dose did not differ significantly after month 0 in patients switched to IIM.

Conclusions: This study demonstrates the comparative safety and efficacy of iron isomaltoside versus iron sucrose, with similar dosing schedules in dialysis patients. Iron isomaltoside is non-inferior to iron sucrose in maintaining Hb in patients on regular haemodialysis/haemodiafiltration with no difference in the number of reported adverse events.
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http://dx.doi.org/10.1186/s12882-020-01866-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7271492PMC
June 2020

The effect of extended-hours hemodialysis on outcomes: A systematic review and meta-analysis.

Hemodial Int 2020 04 5;24(2):133-147. Epub 2020 Mar 5.

Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.

Extended-hours hemodialysis is associated with improvements in quality of life (QoL) and mortality, but it may accelerate the loss of residual kidney function (RKF) and increase vascular access complications. Multiple established databases were systematically searched; randomized and non-randomized studies were pooled separately. QoL outcomes were assessed using standardized mean difference (SMD), vascular access adverse events and mortality were assessed with relative risk ratios (RR). Four hundred seventy-six patients from six trials were eligible. Data from randomized controlled trials (RCTs) could only be synthesized for vascular access adverse events and mortality, which demonstrated no significant change in vascular access adverse events (RR 1.25, 95% CI 0.88 to 1.77) or mortality (RR 2.29, 95% CI 0.60 to 8.71). Pooled data from non-randomized trials demonstrated no significant difference in QoL (SF-36 Physical Component Summary SMD 0.61, 95% CI -0.10 to 1.31, SF-36 Mental Component Summary SMD -0.04, 95% CI -0.61 to 0.54). RKF was assessed in one report which demonstrated a potential reduction over 12 months with extended-hours hemodialysis. The majority of trials had high risk of bias. Extended-hours hemodialysis was not associated with improved QoL or mortality, or increased vascular access events. Adequately powered RCTs are needed to fully assess extended-hours hemodialysis.
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http://dx.doi.org/10.1111/hdi.12828DOI Listing
April 2020

Standardising the measurement of physical activity in people receiving haemodialysis: considerations for research and practice.

BMC Nephrol 2019 12 4;20(1):450. Epub 2019 Dec 4.

Department of Respiratory Science, University of Leicester, Leicester Kidney Lifestyle Team, Academic Unit, Leicester General Hospital, Gwendolen Road, Leicester, LE4 5PW, UK.

Background: Physical activity (PA) is exceptionally low amongst the haemodialysis (HD) population, and physical inactivity is a powerful predictor of mortality, making it a prime focus for intervention. Objective measurement of PA using accelerometers is increasing, but standard reporting guidelines essential to effectively evaluate, compare and synthesise the effects of PA interventions are lacking. This study aims to (i) determine the measurement and processing guidance required to ensure representative PA data amongst a diverse HD population, and; (ii) to assess adherence to PA monitor wear amongst HD patients.

Methods: Clinically stable HD patients from the UK and China wore a SenseWear Armband accelerometer for 7 days. Step count between days (HD, Weekday, Weekend) were compared using repeated measures ANCOVA. Intraclass correlation coefficients (ICCs) determined reliability (≥0.80 acceptable). Spearman-Brown prophecy formula, in conjunction with a priori ≥  80% sample size retention, identified the minimum number of days required for representative PA data.

Results: Seventy-seven patients (64% men, mean ± SD age 56 ± 14 years, median (interquartile range) time on HD 40 (19-72) months, 40% Chinese, 60% British) participated. Participants took fewer steps on HD days compared with non-HD weekdays and weekend days (3402 [95% CI 2665-4140], 4914 [95% CI 3940-5887], 4633 [95% CI 3558-5707] steps/day, respectively, p < 0.001). PA on HD days were less variable than non-HD days, (ICC 0.723-0.839 versus 0.559-0.611) with ≥ 1 HD day and ≥  3 non-HD days required to provide representative data. Using these criteria, the most stringent wear-time retaining ≥ 80% of the sample was ≥7 h.

Conclusions: At group level, a wear-time of ≥7 h on ≥1HD day and ≥ 3 non-HD days is required to provide reliable PA data whilst retaining an acceptable sample size. PA is low across both HD and non- HD days and future research should focus on interventions designed to increase physical activity in both the intra and interdialytic period.
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http://dx.doi.org/10.1186/s12882-019-1634-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6894215PMC
December 2019

Prevalence and correlates of physical activity across kidney disease stages: an observational multicentre study.

Nephrol Dial Transplant 2021 03;36(4):641-649

Department of Health Sciences, Leicester Kidney Lifestyle Team, University of Leicester, Leicester, UK.

Background: People with chronic kidney disease (CKD) report high levels of physical inactivity, a major modifiable risk factor for morbidity and mortality. Understanding the biological, psychosocial and demographic causes of physical activity behaviour is essential for the development and improvement of potential health interventions and promotional initiatives. This study investigated the prevalence of physical inactivity and determined individual correlates of this behaviour in a large sample of patients across the spectrum of kidney disease.

Methods: A total of 5656 people across all stages of CKD (1-2, 3, 4-5, haemodialysis, peritoneal dialysis and renal transplant recipients) were recruited from 17 sites in England from July 2012 to October 2018. Physical activity was evaluated using the General Practice Physical Activity Questionnaire. Self-reported cardiorespiratory fitness, self-efficacy and stage of change were also assessed. Binominal generalized linear mutually adjusted models were conducted to explore the associations between physical activity and correlate variables. This cross-sectional observational multi-centre study was registered retrospectively as ISRCTN87066351 (October 2015).

Results: The prevalence of physical activity (6-34%) was low and worsened with disease progression. Being older, female and having a greater number of comorbidities were associated with greater odds of being physically inactive. Higher haemoglobin, cardiorespiratory fitness and self-efficacy levels were associated with increased odds of being active. Neither ethnicity nor smoking history had any effect on physical activity.

Conclusions: Levels of physical inactivity are high across all stages of CKD. The identification of stage-specific correlates of physical activity may help to prioritize factors in target groups of kidney patients and improve the development and improvement of public health interventions.
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http://dx.doi.org/10.1093/ndt/gfz235DOI Listing
March 2021

The Efficacy of Prebiotic, Probiotic, and Synbiotic Supplementation in Modulating Gut-Derived Circulatory Particles Associated With Cardiovascular Disease in Individuals Receiving Dialysis: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

J Ren Nutr 2020 07 10;30(4):347-359. Epub 2019 Oct 10.

Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom; John Walls Renal Unit, University Hospitals Leicester NHS Trust, Leicester, United Kingdom; School of Sport, Exercise & Health Sciences, Loughborough University, United Kingdom.

Objective: This systematic review and meta-analyses provide an up-to-date synthesis on the effects of supplementation on circulating levels of toxic metabolites, markers of uremia and inflammation, blood lipids, and other clinical outcomes.

Methods: Seventeen databases were searched, supplemented with internet and hand searching. Randomized controlled trials of adult end-stage renal-disease individuals receiving either hemodialysis or peritoneal dialysis were eligible. Trials were restricted to those which had administered a prebiotic, probiotic, or synbiotic as an oral supplement. Primary outcomes were measures of circulating endotoxin, indoxyl-sulphate, and p-cresyl sulfate.

Results: Twenty-one trials were eligible (1152 randomized participants), of which 16 trials were considered to have a high risk of bias. The number of trials available for meta-analysis varied for each primary outcome. Synthesized data indicated that supplementation significantly reduced circulating levels of endotoxin (standardized mean difference, -0.61; 95% confidence interval, -1.03 to -0.20; P = .004; I = 0%), indoxyl-sulphate (-0.34; -0.64 to -0.04; P = .02; I = 0%), and p-cresyl sulfate (-0.34; -0.61 to -0.07; P = .01; I = 0%). For secondary outcomes, supplementation significantly reduced gastrointestinal symptoms (-0.54; -1.02 to -0.07; P = .02; I = 0%).

Conclusions: Supplementation reduces toxic metabolites associated with cardiovascular disease and mortality in individuals receiving dialysis. However, the majority of trials included were low in quality.
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http://dx.doi.org/10.1053/j.jrn.2019.07.006DOI Listing
July 2020

Co-producing Progression Criteria for Feasibility Studies: A Partnership between Patient Contributors, Clinicians and Researchers.

Int J Environ Res Public Health 2019 10 6;16(19). Epub 2019 Oct 6.

Department of Health Sciences, University of Leicester, Leicester LE1 7RH, UK.

There is a lack of guidance for developing progression criteria (PC) within feasibility studies. We describe a process for co-producing PC for an ongoing feasibility study. Patient contributors, clinicians and researchers participated in discussions facilitated using the modified Nominal Group Technique (NGT). Stage one involved individual discussion groups used to develop and rank PC for aspects of the trial key to feasibility. A second stage involving representatives from each of the individual groups then discussed and ranked these PC. The highest ranking PC became the criteria used. At each stage all members were provided with a brief education session to aid understanding and decision-making. Fifty members (15 (29%) patients, 13 (25%) researchers and 24 (46%) clinicians) were involved in eight initial groups, and eight (two (25%) patients, five (62%) clinicians, one (13%) researcher) in one final group. PC relating to eligibility, recruitment, intervention and outcome acceptability and loss to follow-up were co-produced. Groups highlighted numerous means of adapting intervention and trial procedures should 'change' criteria be met. Modified NGT enabled the equal inclusion of patients, clinician and researcher in the co-production of PC. The structure and processes provided a transparent mechanism for setting PC that could be replicated in other feasibility studies.
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http://dx.doi.org/10.3390/ijerph16193756DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6801439PMC
October 2019
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