Publications by authors named "Lai Seong Hooi"

32 Publications

Clinical effectiveness of a Malaysian-manufactured CAPD product: A randomised trial.

Perit Dial Int 2021 Mar 18:896860821993954. Epub 2021 Mar 18.

Department of Medicine, Sultanah Aminah Hospital, Ministry of Health Malaysia, Johor Bahru, Malaysia.

Background: We compared the clinical effectiveness of a new peritoneal dialysis (PD) product with polyvinyl chloride-containing tubing (Stay Safe Link®, SSL) with the plastic-free alternative (Stay Safe®, STS) in patients on continuous ambulatory peritoneal dialysis (CAPD).

Method: A multicentre, parallel, randomised, controlled, open-label, non-inferiority trial was conducted. Adult patients receiving CAPD were randomised in a 1:1 ratio to SSL or STS. The primary outcome was the rate of peritonitis after 1 year of follow-up.

Results: A total of 472 subjects were randomised (SSL, = 233; STS, = 239). One subject in each group was excluded from the analysis as they withdrew consent before the first dialysis dose. Four hundred and seventy subjects (SSL, = 232; STS, = 238) were included in the modified intention-to-treat analysis. Non-inferiority between two groups was established as no significant difference was found in peritonitis rate (incident rate ratio: 0.91, 95% CI: 0.65-1.28). No significant difference was detected in weekly Kt/V ( = 0.58) and creatinine clearance ( = 0.55). However, the average ultrafiltration volume was significantly lower in SSL, with a mean difference of 93 ml ( < 0.01). SSL also demonstrated a 2.57-times higher risk of device defect than STS (95% CI: 1.77-3.75).

Conclusion: SSL was non-inferior in peritonitis rate compared to plastic-free STS over 1 year in patients requiring CAPD. There was no difference in the delivered dialysis dose, but there was a higher rate of device defects with SSL.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/0896860821993954DOI Listing
March 2021

A Randomized Trial on the Effect of Phosphate Reduction on Vascular End Points in CKD (IMPROVE-CKD).

J Am Soc Nephrol 2020 11 11;31(11):2653-2666. Epub 2020 Sep 11.

Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.

Background: Hyperphosphatemia is associated with increased fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality. Effects of phosphate-lowering medication on vascular calcification and arterial stiffness in CKD remain uncertain.

Methods: To assess the effects of non-calcium-based phosphate binders on intermediate cardiovascular markers, we conducted a multicenter, double-blind trial, randomizing 278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg lanthanum carbonate or matched placebo thrice daily for 96 weeks. We analyzed the primary outcome, carotid-femoral pulse wave velocity, using a linear mixed effects model for repeated measures. Secondary outcomes included abdominal aortic calcification and serum and urine markers of mineral metabolism.

Results: A total of 138 participants received lanthanum and 140 received placebo (mean age 63.1 years; 69% male, 64% White). Mean eGFR was 26.6 ml/min per 1.73 m; 45% of participants had diabetes and 32% had cardiovascular disease. Mean serum phosphate was 1.25 mmol/L (3.87 mg/dl), mean pulse wave velocity was 10.8 m/s, and 81.3% had abdominal aortic calcification at baseline. At 96 weeks, pulse wave velocity did not differ significantly between groups, nor did abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate. Serious adverse events occurred in 63 (46%) participants prescribed lanthanum and 66 (47%) prescribed placebo. Although recruitment to target was not achieved, additional analysis suggested this was unlikely to have significantly affected the principle findings.

Conclusions: In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo. These findings do not support the role of intestinal phosphate binders to reduce cardiovascular risk in patients with CKD who have normophosphatemia.

Clinical Trial Registry Name And Registration Number: Australian Clinical Trials Registry, ACTRN12610000650099.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1681/ASN.2020040411DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7608977PMC
November 2020

Prevalence of chronic kidney disease and its associated factors in Malaysia; findings from a nationwide population-based cross-sectional study.

BMC Nephrol 2020 08 14;21(1):344. Epub 2020 Aug 14.

Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, Shah Alam, Selangor, Malaysia.

Background: The prevalence of chronic kidney disease (CKD) in Malaysia was 9.07% in 2011. We aim to determine the current CKD prevalence in Malaysia and its associated risk factors.

Methods: A population-based study was conducted on a total of 890 respondents who were representative of the adult population in Malaysia, i.e., aged ≥18 years old. Respondents were randomly selected using a stratified cluster method. The estimated glomerular filtration rate (eGFR) was estimated from calibrated serum creatinine using the CKD-EPI equation. CKD was defined as eGFR < 60 ml/min/1.73m or the presence of persistent albuminuria if eGFR ≥60 ml/min/1.73m.

Results: Our study shows that the prevalence of CKD in Malaysia was 15.48% (95% CI: 12.30, 19.31) in 2018, an increase compared to the year 2011 when the prevalence of CKD was 9.07%. An estimated 3.85% had stage 1 CKD, 4.82% had stage 2 CKD, and 6.48% had stage 3 CKD, while 0.33% had stage 4-5 CKD. Hypertension (aOR 3.72), diabetes mellitus (aOR 3.32), increasing BMI (aOR 1.06), and increasing age (aOR 1.06) were significantly associated with CKD.

Conclusion: Our study has shown that CKD has become one of the leading public health issues in Malaysia. Thus, there is an urgent need to screen for CKD and prevent its progression, associated morbidity, and mortality at the national level.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12882-020-01966-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427283PMC
August 2020

Cost utility analysis of end stage renal disease treatment in Ministry of Health dialysis centres, Malaysia: Hemodialysis versus continuous ambulatory peritoneal dialysis.

PLoS One 2019 23;14(10):e0218422. Epub 2019 Oct 23.

Nephrology Unit, Faculty of Medicine, Pusat Perubatan Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.

Objectives: In Malaysia, there is exponential growth of patients on dialysis. Dialysis treatment consumes a considerable portion of healthcare expenditure. Comparative assessment of their cost effectiveness can assist in providing a rational basis for preference of dialysis modalities.

Methods: A cost utility study of hemodialysis (HD) and continuous ambulatory peritoneal dialysis (CAPD) was conducted from a Ministry of Health (MOH) perspective. A Markov model was also developed to investigate the cost effectiveness of increasing uptake of incident CAPD to 55% and 60% versus current practice of 40% CAPD in a five-year temporal horizon. A scenario with 30% CAPD was also measured. The costs and utilities were sourced from published data which were collected as part of this study. The transitional probabilities and survival estimates were obtained from the Malaysia Dialysis and Transplant Registry (MDTR). The outcome measures were cost per life year (LY), cost per quality adjusted LY (QALY) and incremental cost effectiveness ratio (ICER) for the Markov model. Sensitivity analyses were performed.

Results: LYs saved for HD was 4.15 years and 3.70 years for CAPD. QALYs saved for HD was 3.544 years and 3.348 for CAPD. Cost per LY saved was RM39,791 for HD and RM37,576 for CAPD. The cost per QALY gained was RM46,595 for HD and RM41,527 for CAPD. The Markov model showed commencement of CAPD in 50% of ESRD patients as initial dialysis modality was very cost-effective versus current practice of 40% within MOH. Reduction in CAPD use was associated with higher costs and a small devaluation in QALYs.

Conclusions: These findings suggest provision of both modalities is fiscally feasible; increasing CAPD as initial dialysis modality would be more cost-effective.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0218422PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6808325PMC
March 2020

Identifying critically important vascular access outcomes for trials in haemodialysis: an international survey with patients, caregivers and health professionals.

Nephrol Dial Transplant 2020 04;35(4):657-668

Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia.

Background: Vascular access outcomes reported across haemodialysis (HD) trials are numerous, heterogeneous and not always relevant to patients and clinicians. This study aimed to identify critically important vascular access outcomes.

Method: Outcomes derived from a systematic review, multi-disciplinary expert panel and patient input were included in a multilanguage online survey. Participants rated the absolute importance of outcomes using a 9-point Likert scale (7-9 being critically important). The relative importance was determined by a best-worst scale using multinomial logistic regression. Open text responses were analysed thematically.

Results: The survey was completed by 873 participants [224 (26%) patients/caregivers and 649 (74%) health professionals] from 58 countries. Vascular access function was considered the most important outcome (mean score 7.8 for patients and caregivers/8.5 for health professionals, with 85%/95% rating it critically important, and top ranked on best-worst scale), followed by infection (mean 7.4/8.2, 79%/92% rating it critically important, second rank on best-worst scale). Health professionals rated all outcomes of equal or higher importance than patients/caregivers, except for aneurysms. We identified six themes: necessity for HD, applicability across vascular access types, frequency and severity of debilitation, minimizing the risk of hospitalization and death, optimizing technical competence and adherence to best practice and direct impact on appearance and lifestyle.

Conclusions: Vascular access function was the most critically important outcome among patients/caregivers and health professionals. Consistent reporting of this outcome across trials in HD will strengthen their value in supporting vascular access practice and shared decision making in patients requiring HD.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ndt/gfz148DOI Listing
April 2020

Health related quality of life of dialysis patients in Malaysia: Haemodialysis versus continuous ambulatory peritoneal dialysis.

BMC Nephrol 2019 04 30;20(1):151. Epub 2019 Apr 30.

Nephrology Unit, Faculty of Medicine, Pusat Perubatan Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, Cheras, 56000, Kuala Lumpur, Malaysia.

Background: Health related quality of life (HRQOL) is an important predictor of clinical outcomes for End Stage Renal Disease (ESRD) patients and to establish quality adjusted life years (QALYs) for economic evaluation studies. This study aims to measure the health utilities and to identify socio-demographic and clinical factors associated with HRQOL for haemodialysis (HD) and continuous ambulatory peritoneal dialysis (CAPD) in Malaysia.

Methods: A total of 141 patients (77 HD and 64 CAPD) from 1 federal and four state hospitals participated in this cross-sectional study. Patients were randomly selected from the National Renal Registry (NRR) using a stratified random sampling. The EQ-5D-3 L questionnaire was used to measure HRQOL. Variables investigated include dialysis modalities, sociodemographic characteristics, co-morbidities and biochemical markers. Utilities are measured on an ordinal scale of 0-1, where 1 indicates full health and 0 indicates death.

Results: The mean utility scores were 0.854 ± 0.181 and 0.905 ± 0.124 (p > 0.05) and the mean Visual Analogue Scale (VAS) scores were 76.2 ± 12.90 and 77.1 ± 10.26 (p > 0.05) for HD and CAPD patients respectively. There was a significant difference in problems reported between HD (35.1%) and CAPD (15.6%) on usual activities dimension (p = 0.009). The proportion of patients having problems in the pain/discomfort domain in both modalities was high (34.0%). Haemoglobin (< 10 g/dL) (p = 0.003), number of co-morbidities ≥3 (p = 0.004) and wheelchair-bound status (p < 0.001) were significant predictors of poor HRQOL.

Conclusions: The present cross-sectional study shows that CAPD patients have a higher utility index score than HD patients but this was not statistically significant. The utilities index score may be used to calculate QALYs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12882-019-1326-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6492391PMC
April 2019

Fish oil and aspirin effects on arteriovenous fistula function: Secondary outcomes of the randomised omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) trial.

PLoS One 2019 26;14(3):e0213274. Epub 2019 Mar 26.

The George Institute for Global Health, Sydney, Australia.

Background: Arteriovenous fistulas (AVF) for haemodialysis often experience early thrombosis and maturation failure requiring intervention and/or central venous catheter (CVC) placement. This secondary and exploratory analysis of the FAVOURED study determined whether omega-3 fatty acids (fish oils) or aspirin affected AVF usability, intervention rates and CVC requirements.

Methods: In 567 adult participants planned for AVF creation, all were randomised to fish oil (4g/d) or placebo, and 406 to aspirin (100mg/d) or placebo, starting one day pre-surgery and continued for three months. Outcomes evaluated within 12 months included AVF intervention rates, CVC exposure, late dialysis suitability failure, and times to primary patency loss, abandonment and successful cannulation.

Results: Final analyses included 536 participants randomised to fish oil or placebo (mean age 55 years, 64% male, 45% diabetic) and 388 randomised to aspirin or placebo. Compared with placebo, fish oil reduced intervention rates (0.82 vs 1.14/1000 patient-days, incidence rate ratio [IRR] 0.72, 95% confidence interval [CI] 0.54-0.97), particularly interventions for acute thrombosis (0.09 vs 0.17/1000 patient-days, IRR 0.53, 95% CI 0.34-0.84). Aspirin significantly reduced rescue intervention rates (IRR 0.45, 95% CI 0.27-0.78). Neither agent significantly affected CVC exposure, late dialysis suitability failure or time to primary patency loss, AVF abandonment or successful cannulation.

Conclusion: Although fish oil and low-dose aspirin given for 3 months reduced intervention rates in newly created AVF, they had no significant effects on CVC exposure, AVF usability and time to primary patency loss or access abandonment. Reduction in access interventions benefits patients, reduces costs and warrants further study.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0213274PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6435148PMC
December 2019

Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis.

BMJ Open 2019 03 8;9(3):e024589. Epub 2019 Mar 8.

Nephrology Unit, Hospital Sultanah Aminah, Johor Bahru, Malaysia.

Introduction: Peritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.

Methods And Analysis: The study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.

Ethics And Dissemination: The study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.

Trial Registration Number: NCT03177031; Pre-results.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2018-024589DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6429925PMC
March 2019

Nephrology in the Oceania-South East Asia region: perspectives and challenges.

Kidney Int 2018 09 23;94(3):465-470. Epub 2018 Jul 23.

Division of Nephrology, University of British Columbia, Vancouver, British Columbia, Canada; BC Provincial Renal Agency, Vancouver, British Columbia, Canada.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.kint.2018.05.014DOI Listing
September 2018

Glomerular Filtration Rates in Asians.

Adv Chronic Kidney Dis 2018 01;25(1):41-48

Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore; Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China; Faculty of Renal Care, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Division of Nephrology, Department of Medicine, University of Hong Kong, Hong Kong, China; George Institute for Global Health, New Delhi, India; Division of Nephrology, Ewha Women's University School of Medicine, Korea; Ateneo School of Medicine and Public Health, Pasig, Philippines; Hospital Sultanah Aminah, Johor Bahru, Malaysia; Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Qianfoshan Hospital, Shandong University, Jinan, China; and the Department of Medicine, National University Health System, Singapore, Singapore.

The National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines recommended the Modification of Diet in Renal Disease study equation for estimating glomerular filtration rate (GFR) for the classification of CKD, but its accuracy was limited to North American patients with estimated GFR <60 mL/min per 1.73 m body surface area of European (White) or African (Black) descent. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) developed another equation for estimating GFR, derived from a population that included both participants without kidney disease and with CKD. But many ethnicities were inadequately represented. The International Society of Nephrology, Kidney Disease Improving Global Outcomes committee promulgated clinical practice guidelines, which recommended the CKD-EPI equation. Investigators in Asia subsequently assessed the performance of these GFR estimating equations-the Modification of Diet in Renal Disease study equation, the CKD-EPI equation (creatinine only), and the CKD-EPI equations (creatinine and cystatin C). In this review, we summarize the studies performed in Asia on validating or establishing new Asian ethnicity GFR estimating equations. We included both prospective and retrospective studies which used serum markers traceable to reference materials and focused the review of the performance of GFR estimation by comparisons with the GFR estimations obtained from the CKD-EPI equations.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1053/j.ackd.2017.10.005DOI Listing
January 2018

Report of the Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop on Establishing a Core Outcome Measure for Hemodialysis Vascular Access.

Am J Kidney Dis 2018 05 23;71(5):690-700. Epub 2018 Feb 23.

Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia; Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Australia; Translational Research Institute, Brisbane, Australia.

Vascular access outcomes in hemodialysis are critically important for patients and clinicians, but frequently are neither patient relevant nor measured consistently in randomized trials. A Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop was convened to discuss the development of a core outcome measure for vascular access. 13 patients/caregivers and 46 professionals (clinicians, policy makers, industry representatives, and researchers) attended. Participants advocated for vascular access function to be a core outcome based on the broad applicability of function regardless of access type, involvement of a multidisciplinary team in achieving a functioning access, and the impact of access function on quality of life, survival, and other access-related outcomes. A core outcome measure for vascular access required demonstrable feasibility for implementation across different clinical and trial settings. Participants advocated for a practical and flexible outcome measure with a simple actionable definition. Integrating patients' values and preferences was warranted to enhance the relevance of the measure. Proposed outcome measures for function included "uninterrupted use of the access without the need for interventions" and "ability to receive prescribed dialysis," but not "access blood flow," which was deemed too expensive and unreliable. These recommendations will inform the definition and implementation of a core outcome measure for vascular access function in hemodialysis trials.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1053/j.ajkd.2017.12.003DOI Listing
May 2018

Dialysis Provision and Implications of Health Economics on Peritoneal Dialysis Utilization: A Review from a Malaysian Perspective.

Int J Nephrol 2017 31;2017:5819629. Epub 2017 Oct 31.

Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur, Malaysia.

End-stage renal disease (ESRD) is managed by either lifesaving hemodialysis (HD) and peritoneal dialysis (PD) or a kidney transplant. In Malaysia, the prevalence of dialysis-treated ESRD patients has shown an exponential growth from 504 per million population (pmp) in 2005 to 1155 pmp in 2014. There were 1046 pmp patients on HD and 109 pmp patients on PD in 2014. Kidney transplants are limited due to lack of donors. Malaysia adopts public-private financing model for dialysis. Majority of HD patients were treated in the private sector but almost all PD patients were treated in government facilities. Inequality in access to dialysis is visible within geographical regions where majority of HD centres are scattered around developed areas. The expenditure on dialysis has been escalating in recent years but economic evaluations of dialysis modalities are scarce. Evidence shows that health policies and reimbursement strategies influence dialysis provision. Increased uptake of PD can produce significant economic benefits and improve patients' access to dialysis. As a result, some countries implemented a PD-First or Favored Policy to expand PD use. Thus, a current comparative costs analysis of dialysis is strongly recommended to assist decision-makers to establish a more equitable and economically sustainable dialysis provision in the future.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1155/2017/5819629DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5684550PMC
October 2017

Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials: A Systematic Review.

Am J Kidney Dis 2018 03 6;71(3):382-391. Epub 2017 Dec 6.

Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia; Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Australia; Translational Research Institute, Brisbane, Australia.

Background: Many randomized controlled trials have been performed with the goal of improving outcomes related to hemodialysis vascular access. If the reported outcomes are relevant and measured consistently to allow comparison of interventions across trials, such trials can inform decision making. This study aimed to assess the scope and consistency of vascular access outcomes reported in contemporary hemodialysis trials.

Study Design: Systematic review.

Setting & Population: Adults requiring maintenance hemodialysis.

Selection Criteria: All randomized controlled trials and trial protocols reporting vascular access outcomes identified from ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016.

Interventions: Any hemodialysis-related intervention.

Outcomes: The frequency and characteristics of vascular access outcome measures were analyzed and classified.

Results: From 168 relevant trials, 1,426 access-related outcome measures were extracted and classified into 23 different outcomes. The 3 most common outcomes were function (136 [81%] trials), infection (63 [38%]), and maturation (31 [18%]). Function was measured in 489 different ways, but most frequently reported as "mean access blood flow (mL/min)" (37 [27%] trials) and "number of thromboses" (30 [22%]). Infection was assessed in 136 different ways, with "number of access-related infections" being the most common measure. Maturation was assessed in 44 different ways at 15 different time points and most commonly characterized by vein diameter and blood flow. Patient-reported outcomes, including pain (19 [11%]) and quality of life (5 [3%]), were reported infrequently. Only a minority of trials used previously standardized outcome definitions.

Limitations: Restricted sampling frame for feasibility and focus on contemporary trials.

Conclusions: The reporting of access outcomes in hemodialysis trials is very heterogeneous, with limited patient-reported outcomes and infrequent use of standardized outcome measures. Efforts to standardize outcome reporting for vascular access are critical to optimizing the comparability, reliability, and value of trial evidence to improve outcomes for patients requiring hemodialysis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1053/j.ajkd.2017.09.018DOI Listing
March 2018

Acute Kidney Injury Risk Assessment: Differences and Similarities Between Resource-Limited and Resource-Rich Countries.

Kidney Int Rep 2017 Jul 25;2(4):519-529. Epub 2017 Apr 25.

Division of Nephrology and Hypertension, Department of Medicine, University of California-San Diego, San Diego, California, USA.

The incidence of acute kidney injury (AKI) among acutely ill patients is reportedly very high and has vexing consequences on patient outcomes and health care systems. The risks and impact of AKI differ between developed and developing countries. Among developing countries, AKI occurs in young individuals with no or limited comorbidities, and is usually due to environmental causes, including infectious diseases. Although several risk factors have been identified for AKI in different settings, there is limited information on how risk assessment can be used at population and patient levels to improve care in patients with AKI, particularly in developing countries where significant health disparities may exist. The Acute Disease Quality Initiative consensus conference work group addressed the issue of identifying risk factors for AKI and provided recommendations for developing individualized risk stratification strategies to improve care. We proposed a 5-dimension, evidence-based categorization of AKI risk that allows clinicians and investigators to study, define, and implement individualized risk assessment tools for the region or country where they practice. These dimensions include environmental, socioeconomic and cultural factors, processes of care, exposures, and the inherent risks of AKI. We provide examples of these risks and describe approaches for risk assessments in the developing world. We anticipate that these recommendations will be useful for health care providers to plan and execute interventions to limit the impact of AKI on society and each individual patient. Using a modified Delphi process, this group reached consensus regarding several aspects of AKI risk stratification.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ekir.2017.03.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5568820PMC
July 2017

Effect of Fish Oil Supplementation and Aspirin Use on Arteriovenous Fistula Failure in Patients Requiring Hemodialysis: A Randomized Clinical Trial.

JAMA Intern Med 2017 02;177(2):184-193

Department of Nephrology, Monash Medical Centre, Melbourne, Australia10Department of Medicine, Monash University, Melbourne, Australia13School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Importance: Vascular access dysfunction is a leading cause of morbidity and mortality in patients requiring hemodialysis. Arteriovenous fistulae are preferred over synthetic grafts and central venous catheters due to superior long-term outcomes and lower health care costs, but increasing their use is limited by early thrombosis and maturation failure. ω-3 Polyunsaturated fatty acids (fish oils) have pleiotropic effects on vascular biology and inflammation and aspirin impairs platelet aggregation, which may reduce access failure.

Objective: To determine whether fish oil supplementation (primary objective) or aspirin use (secondary objective) is effective in reducing arteriovenous fistula failure.

Design, Setting, And Participants: The Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) study was a randomized, double-blind, controlled clinical trial that recruited participants with stage 4 or 5 chronic kidney disease from 2008 to 2014 at 35 dialysis centers in Australia, Malaysia, New Zealand, and the United Kingdom. Participants were observed for 12 months after arteriovenous fistula creation.

Interventions: Participants were randomly allocated to receive fish oil (4 g/d) or matching placebo. A subset (n = 406) was also randomized to receive aspirin (100 mg/d) or matching placebo. Treatment started 1 day prior to surgery and continued for 12 weeks.

Main Outcomes And Measures: The primary outcome was fistula failure, a composite of fistula thrombosis and/or abandonment and/or cannulation failure, at 12 months. Secondary outcomes included the individual components of the primary outcome.

Results: Of 1415 eligible participants, 567 were randomized (359 [63%] male, 298 [53%] white, 264 [47%] with diabetes; mean [SD] age, 54.8 [14.3] y). The same proportion of fistula failures occurred in the fish oil and placebo arms (128 of 270 [47%] vs 125 of 266 [47%]; relative risk [RR] adjusted for aspirin use, 1.03; 95% CI, 0.86-1.23; P = .78). Fish oil did not reduce fistula thrombosis (60 [22%] vs 61 [23%]; RR, 0.98; 95% CI, 0.72-1.34; P = .90), abandonment (51 [19%] vs 58 [22%]; RR, 0.87; 95% CI, 0.62-1.22; P = .43), or cannulation failure (108 [40%] vs 104 [39%]; RR, 1.03; 95% CI, 0.83-1.26; P = .81). The risk of fistula failure was similar between the aspirin and placebo arms (87 of 194 [45%] vs 83 of 194 [43%]; RR, 1.05; 95% CI, 0.84-1.31; P = .68).

Conclusions And Relevance: Neither fish oil supplementation nor aspirin use reduced failure of new arteriovenous fistulae within 12 months of surgery.

Trial Registration: anzctr.org.au Identifier: CTRN12607000569404.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamainternmed.2016.8029DOI Listing
February 2017

Risk of Peritoneal Dialysis-Related Peritonitis in a Multi-Racial Asian Population.

Perit Dial Int 2017 1-2;37(1):35-43. Epub 2016 May 4.

Department of Nephrology, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia.

♦ BACKGROUND: Peritonitis is one of the most common complications of peritoneal dialysis (PD). Understanding the risk factors of peritonitis in a multi-racial Asian population may help to improve outcomes on PD. ♦ METHODS: We conducted a prospective observational study to identify risk factors for PD-related peritonitis over a 1-year period in 15 adult PD centers. All peritonitis episodes were independently adjudicated. ♦ RESULTS: A total of 1,603 participants with a mean age of 51.6 years comprising 52.7% females, 62.6% ethnic Malays, 27.0% Chinese, and 8.1% Indians were recruited. The overall peritonitis rate was 1 episode per 44.0 patient-months with 354 episodes recorded in 282 (17.6%) patients over 15,588 patient-months. Significant risk factors of peritonitis were severe obesity (incidence-rate ratio [IRR] 3.32, 95% confidence interval [CI]: 1.30, 8.45), hypoalbuminemia (IRR 1.61, 95% CI: 1.06, 2.46), Staphylococcus aureus nasal carriage (IRR 2.26, 95% CI: 1.46, 3.50), and use of Fresenius system (Fresenius Medical Care North America, Waltham, MA, USA) (IRR 2.49, 95% CI: 1.27, 4.89). The risk of peritonitis was lower in those on automated PD compared with standard PD (IRR 0.43, 95% CI: 0.25, 0.74), and in centers with a patient-staff ratio of 15 to 29.9 (IRR 0.67, 95% CI: 0.49, 0.90) and ≥ 30 (IRR 0.52, 95% CI: 0.34, 0.80). Prevalent patients and exit-site care with topical antibiotics were also protective against peritonitis. Peritonitis rates varied between racial groups. The IRRs of overall peritonitis and gram-positive peritonitis in Chinese versus other racial groups were 0.65 (95% CI: 0.46, 0.90) and 0.47 (95% CI: 0.24, 0.91), respectively. ♦ CONCLUSIONS: Multiple patient, center, and PD-system factors influence the risk of peritonitis. In the Asian population, there are racial differences in the risk of peritonitis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3747/pdi.2015.00141DOI Listing
December 2017

The effect of lowering LDL cholesterol on vascular access patency: post hoc analysis of the Study of Heart and Renal Protection.

Clin J Am Soc Nephrol 2014 May 13;9(5):914-9. Epub 2014 Mar 13.

Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.

Background And Objectives: Reducing LDL cholesterol (LDL-C) with statin-based therapy reduces the risk of major atherosclerotic events among patients with CKD, including dialysis patients, but the effect of lowering LDL-C on vascular access patency is unclear.

Design, Setting, Participants, & Measurements: The Study of Heart and Renal Protection (SHARP) randomized patients with CKD to 20 mg simvastatin plus 10 mg ezetimibe daily versus matching placebo. This study aimed to explore the effects of treatment on vascular access occlusive events, defined as any access revision procedure, access thrombosis, removal of an old dialysis access, or formation of new permanent dialysis access.

Results: Among 2353 SHARP participants who had functioning vascular access at randomization, allocation to simvastatin plus ezetimibe resulted in a 13% proportional reduction in vascular access occlusive events (355 [29.7%] for simvastatin/ezetimibe versus 388 [33.5%] for placebo; risk ratio [RR], 0.87; 95% confidence interval [95% CI], 0.75 to 1.00; P=0.05). There was no evidence that the effects of treatment differed for any of the separate components of this outcome. To test the hypothesis raised by SHARP, comparable analyses were performed using the AURORA (A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events) trial cohort. AURORA did not provide independent confirmation (vascular access occlusive events: 352 [28.9%] for rosuvastatin versus 337 [27.6%] for placebo; RR, 1.06, 95% CI, 0.91 to 1.23; P=0.44). After combining the two trials, the overall effect of reducing LDL-C with a statin-based regimen on vascular access occlusive events was not statistically significant (707 [29.3%] with any LDL-C-lowering therapy versus 725 [30.5%] with placebo; RR, 0.95, 95% CI, 0.85 to 1.05; P=0.29).

Conclusions: Exploratory analyses from SHARP suggest that lowering LDL-C with statin-based therapy may improve vascular access patency, but there was no evidence of benefit in AURORA. Taken together, the available evidence suggests that any benefits of lowering LDL-C on vascular access patency are likely to be modest.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2215/CJN.10371013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4011457PMC
May 2014

A population-based study measuring the prevalence of chronic kidney disease among adults in West Malaysia.

Kidney Int 2013 Nov 12;84(5):1034-40. Epub 2013 Jun 12.

Department of Medicine and Haemodialysis Unit, Sultanah Aminah Hospital, Johor Baru, Malaysia.

In this population-based study, we determine the prevalence of chronic kidney disease in West Malaysia in order to have accurate information for health-care planning. A sample of 876 individuals, representative of 15,147 respondents from the National Health and Morbidity Survey 2011, of the noninstitutionalized adult population (over 18 years old) in West Malaysia was studied. We measured the estimated glomerular filtration rate (eGFR) (CKD-EPI equation); albuminuria and stages of chronic kidney disease were derived from calibrated serum creatinine, age, gender and early morning urine albumin creatinine ratio. The prevalence of chronic kidney disease in this group was 9.07%. An estimated 4.16% had stage 1 chronic kidney disease (eGFR >90 ml/min per 1.73 m(2) and persistent albuminuria), 2.05% had stage 2 (eGFR 60-89 ml/min per 1.73 m(2) and persistent albuminuria), 2.26% had stage 3 (eGFR 30-59 ml/min per 1.73 m(2)), 0.24% had stage 4 (eGFR 15-29 ml/min per 1.73 m(2)), and 0.36% had stage 5 chronic kidney disease (eGFR <15 ml/min per 1.73 m(2)). Only 4% of respondents with chronic kidney disease were aware of their diagnosis. Risk factors included increased age, diabetes, and hypertension. Thus, chronic kidney disease in West Malaysia is common and, therefore, warrants early detection and treatment in order to potentially improve outcome.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1038/ki.2013.220DOI Listing
November 2013

Lupus nephritis: induction therapy in severe lupus nephritis--should MMF be considered the drug of choice?

Clin J Am Soc Nephrol 2013 Jan 9;8(1):147-53. Epub 2012 Aug 9.

Department of Medicine, Ohio State University Wexner Medical Center, Columbus, OH 43210, USA.

Severe lupus nephritis is an aggressive disease that requires an aggressive approach to treatment. Recent randomized clinical trials showed that mycophenolate mofetil compared favorably with cyclophosphamide (traditional approach) for remission induction. Consequently, mycophenolate mofetil is now commonly recommended as first-line therapy. Nevertheless, the role of mycophenolate mofetil in treating severe lupus nephritis is unclear, because such patients were excluded from these trials. With this limitation as background, this work addresses the question of mycophenolate mofetil for induction therapy for severe lupus nephritis. We performed a systematic review of the outcomes of treating severe lupus nephritis with mycophenolate mofetil or cyclophosphamide. Because no studies directly addressed this question, these data were extracted from the published literature or obtained by personal communications from investigators. There is no universally accepted definition, and therefore, severe lupus nephritis was arbitrarily defined by renal histology, resistance to therapy, or level of kidney function at presentation. For each trial analyzed, we determined the partial and complete remission rates. Long-term outcomes were compared when available. The pooled results suggest that mycophenolate mofetil and cyclophosphamide are equally effective in inducing remission of severe lupus nephritis. However, relapse rates and risk of developing ESRD were higher for mycophenolate mofetil compared with cyclophosphamide. In conclusion, in the short term, mycophenolate mofetil and cyclophosphamide are about equal in inducing remission. However, long-term outcomes suggest better preservation of kidney function and fewer relapses with cyclophosphamide therapy. Therefore, mycophenolate mofetil should not yet be considered the induction drug of choice for severe lupus nephritis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2215/CJN.03290412DOI Listing
January 2013

The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial.

Lancet 2011 Jun 12;377(9784):2181-92. Epub 2011 Jun 12.

Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK.

Background: Lowering LDL cholesterol with statin regimens reduces the risk of myocardial infarction, ischaemic stroke, and the need for coronary revascularisation in people without kidney disease, but its effects in people with moderate-to-severe kidney disease are uncertain. The SHARP trial aimed to assess the efficacy and safety of the combination of simvastatin plus ezetimibe in such patients.

Methods: This randomised double-blind trial included 9270 patients with chronic kidney disease (3023 on dialysis and 6247 not) with no known history of myocardial infarction or coronary revascularisation. Patients were randomly assigned to simvastatin 20 mg plus ezetimibe 10 mg daily versus matching placebo. The key prespecified outcome was first major atherosclerotic event (non-fatal myocardial infarction or coronary death, non-haemorrhagic stroke, or any arterial revascularisation procedure). All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00125593, and ISRCTN54137607.

Findings: 4650 patients were assigned to receive simvastatin plus ezetimibe and 4620 to placebo. Allocation to simvastatin plus ezetimibe yielded an average LDL cholesterol difference of 0·85 mmol/L (SE 0·02; with about two-thirds compliance) during a median follow-up of 4·9 years and produced a 17% proportional reduction in major atherosclerotic events (526 [11·3%] simvastatin plus ezetimibe vs 619 [13·4%] placebo; rate ratio [RR] 0·83, 95% CI 0·74-0·94; log-rank p=0·0021). Non-significantly fewer patients allocated to simvastatin plus ezetimibe had a non-fatal myocardial infarction or died from coronary heart disease (213 [4·6%] vs 230 [5·0%]; RR 0·92, 95% CI 0·76-1·11; p=0·37) and there were significant reductions in non-haemorrhagic stroke (131 [2·8%] vs 174 [3·8%]; RR 0·75, 95% CI 0·60-0·94; p=0·01) and arterial revascularisation procedures (284 [6·1%] vs 352 [7·6%]; RR 0·79, 95% CI 0·68-0·93; p=0·0036). After weighting for subgroup-specific reductions in LDL cholesterol, there was no good evidence that the proportional effects on major atherosclerotic events differed from the summary rate ratio in any subgroup examined, and, in particular, they were similar in patients on dialysis and those who were not. The excess risk of myopathy was only two per 10,000 patients per year of treatment with this combination (9 [0·2%] vs 5 [0·1%]). There was no evidence of excess risks of hepatitis (21 [0·5%] vs 18 [0·4%]), gallstones (106 [2·3%] vs 106 [2·3%]), or cancer (438 [9·4%] vs 439 [9·5%], p=0·89) and there was no significant excess of death from any non-vascular cause (668 [14·4%] vs 612 [13·2%], p=0·13).

Interpretation: Reduction of LDL cholesterol with simvastatin 20 mg plus ezetimibe 10 mg daily safely reduced the incidence of major atherosclerotic events in a wide range of patients with advanced chronic kidney disease.

Funding: Merck/Schering-Plough Pharmaceuticals; Australian National Health and Medical Research Council; British Heart Foundation; UK Medical Research Council.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S0140-6736(11)60739-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3145073PMC
June 2011

Increasing home-based dialysis therapies to tackle dialysis burden around the world: A position statement on dialysis economics from the 2nd Congress of the International Society for Hemodialysis.

Hemodial Int 2011 Jan 14;15(1):10-4. Epub 2011 Jan 14.

Department of Medicine and Therapeutics, Prince of Wales Hospital, Chinese University of Hong Kong, Sha Tin, Hong Kong SARHospital Authority, Hong Kong SARTung Wah Hospital, Hong KongDepartment of Medicine, University of Washington, Seattle, Washington, USAGeorge Institute for Global Health, Sydney, New South Wales, AustraliaHospital Sultanah Aminah, Johore, MalaysiaYonsei University College of Medicine, Seoul, KoreaAlessandro Manzoni Hospital, Lecco, ItalyPeking University Third Hospital, Beijing, ChinaChang Gung Memorial Hospital, Taipei, TaiwanLapeyronie University Hospital, CHU Montpellier, FranceAlice Ho Miu Ling Nethersole Hospital, Tai Po, Hong KongSingapore General Hospital, Singapore, SingaporeHospital Universitario Valdecilla, Santander, SpainCedars Sinai Medical Center, UCLA, Los Angeles, California, USASocial Insurance Yokohama Central Hospital, Yokohama, JapanMonash Medical Centre, Clayton, AustraliaCentro Hospitalar Conde De s. Januario, Macau, MacauDepartment of Medicine, University of Missouri, Columbia, USAPrincess Margaret Hospital, Kwai Chung, Hong KongChulalongkorn University, Bangkok, ThailandDepartment of Medicine, University of Otago, Dunedin, New ZealandKwong Wah Hospital, Mongkok, Hong Kong.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/j.1542-4758.2010.00512.xDOI Listing
January 2011

Complications after tenckhoff catheter insertion: a single-centre experience using multiple operators over four years.

Perit Dial Int 2010 Sep-Oct;30(5):509-12. Epub 2010 Mar 12.

Haemodialysis Unit, Department of Medicine, Sultanah Aminah Hospital, Johor Bahru, Johor, Malaysia.

Objective: To analyze the complications after Tenckhoff catheter insertion among patients with renal failure needing dialysis. ♢

Patients And Methods: The open, paramedian approach is the commonest technique to insert the 62-cm coiled double-cuffed Tenckhoff peritoneal catheter. All patients with catheters inserted between January 2004 and November 2007 were retrospectively analyzed for demographics and followed for up to 1 month for complications. We excluded patients whose catheters had been anchored to the bladder wall and who underwent concurrent omentectomy or readjustment without removal of a malfunctioning catheter (n = 7). Intravenous cloxacillin was the standard preoperative antibiotic prophylaxis. ♢

Results: Over the 4-year study period, 384 catheters were inserted under local anesthetic into 319 patients [201 women (62.8%); mean age: 49.4 ± 16.7 years (range: 13 - 89 years); 167 (52.2%) with diabetes; 303 (95%) with end-stage renal disease] by 22 different operators. All Tenckhoff catheters were inserted by the general surgical (n = 223) or urology (n = 161) team. There were 29 cases (7.6%) of catheter migration, 22 (5.7%) of catheter obstruction without migration, 24 (6.3%) of exit-site infection, 12 (3.1%) of leak from the main incision, 14 (3.6%) of culture-proven wound infection, 11 (2.9%) post-insertion peritonitis, and 1 (0.3%) hemoperitoneum. No deaths were attributed to surgical mishap. ♢

Conclusions: The most common complication was catheter migration. The paramedian insertion technique was safe, with low complication rates.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3747/pdi.2009.00083DOI Listing
December 2011

A randomized, multicenter, open-label trial to establish therapeutic equivalence between the Carex and ultra disconnect systems in patients on continuous ambulatory peritoneal dialysis.

Perit Dial Int 2003 Dec;23 Suppl 2:S139-43

Department of Medicine, Penang Hospital, Malaysia.

Objective: In the present study, we undertook to establish therapeutic equivalence with respect to peritonitis and technique failure between the Carex disconnect system (B. Braun Carex, Mirandola, Italy) and the standard Ultra system (Baxter Healthcare, Tokyo, Japan) in patients on continuous ambulatory peritoneal dialysis (CAPD).

Design: This multicenter, parallel group, randomized controlled trial involved 363 prevalent CAPD patients from 8 centers. The primary endpoint was peritonitis rate; secondary endpoints were technique failure and technical problems encountered. The duration of the evaluation was 1 year.

Results: The risk of peritonitis on Carex varied between the centers. We found a significant treatment-center interaction effect (likelihood ratio test: p = 0.03). The incidence rate ratio (IRR) of peritonitis on Carex as compared with Ultra ranged from 0.4 to 7.2. In two centers, Carex was inferior to Ultra with regard to peritonitis; but, in five centers, the results were inconclusive. Equivalence was not demonstrated in any center. The overall rate of peritonitis in the Carex group was twice that in the Ultra group [IRR: 2.18; 95% confidence interval (CI): 1.51 to 3.14]. Technique failure and technical problems were more common with the Carex system. Technique failure rate at 1 year was 44% in the Carex group and 22% in the Ultra group.

Conclusions: Equivalence between the Carex disconnect system and the Ultra disconnect system could not be demonstrated. The risk of peritonitis on Carex varied significantly between centers.
View Article and Find Full Text PDF

Download full-text PDF

Source
December 2003

Increased utilization of peritoneal dialysis to cope with mounting demand for renal replacement therapy--perspectives from Asian countries.

Perit Dial Int 2007 Jun;27 Suppl 2:S59-61

Division of Nephrology, Department of Medicine and Therapeutics, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, Hong Kong SAR, PR China.

With the number of end-stage renal disease (ESRD) patients growing, one of the crucial questions facing health care professionals and funding agencies in Asia is whether funding for dialysis will be sufficient to keep up with demand. During the ISPD's 2006 Congress, academic nephrologists and government officials from China, Hong Kong, India, Indonesia, Japan, Macau, Malaysia, Philippines, Singapore, Taiwan, Thailand, and Vietnam participated in a roundtable discussion on dialysis economics in Asia. The focus was policy and health care financing. The roundtable addressed ESRD growth in Asia and how to obtain enough funding to keep up with the growth in patient numbers. Various models were presented: the "peritoneal dialysis (PD) first" policy model, incentive programs, nongovernmental organizations providing PD, and PD reimbursement in a developing economy. This article summarizes the views of the participant nephrologists on how to increase the utilization of PD to improve on clinical and financial management of patients with ESRD.
View Article and Find Full Text PDF

Download full-text PDF

Source
June 2007

A randomized, multicenter, open-label trial to determine peritonitis rate, product defect, and technique survival between ANDY-Disc and UltraBag in patients on CAPD.

Am J Kidney Dis 2006 Sep;48(3):464-72

Department of Nephrology, Institute of Urology and Nephrology.

Background: With the various twin-bag systems available on the market, we decided to conduct a therapeutic equivalence study comparing ANDY-Disc (Fresenius Medical Care, Bad Homburg, Germany) with UltraBag (Baxter, Deerfield, IL) in patients on continuous ambulatory peritoneal dialysis (CAPD) therapy.

Methods: This multicenter, open-label, parallel-group, randomized trial is designed to show the therapeutic equivalence of ANDY-Disc with UltraBag. All CAPD patients from the 6 participating centers who met inclusion/exclusion criteria were enrolled into the trial. They were randomly assigned and converted from the Y-disconnect system (Ultraset; Baxter) to the twin-bag systems. The primary outcome variable is peritonitis, and secondary outcome parameters are technique failure or product defect.

Results: From April 2002 to May 2003, a total of 270 patients were recruited for this study. Overall peritonitis rates were 22.9 patient-months/episode for ANDY-Disc and 35.0 patient-months/episode for UltraBag. The overall peritonitis rate for ANDY-Disc was 53% greater compared with UltraBag, but the 95% confidence interval overlaps the prespecified margin of equivalence. There were more product defects reported with ANDY-Disc; 236 product defects compared with 17 with UltraBag. The time series of the number of product defects and peritonitis count on the ANDY-Disc arm suggests a possible cause-and-effect relationship.

Conclusion: Therapeutic equivalence of ANDY-Disc to UltraBag could not be established with respect to peritonitis. There is a trend toward greater risk for peritonitis on the Andy-Disc arm. There also is a suggestive cause-and-effect relation between the occurrence of product defect and peritonitis on the ANDY-Disc arm during the early part of the trial.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1053/j.ajkd.2006.05.008DOI Listing
September 2006

Randomized controlled trial of pulse intravenous cyclophosphamide versus mycophenolate mofetil in the induction therapy of proliferative lupus nephritis.

Nephrology (Carlton) 2005 Oct;10(5):504-10

Department of Medicine, Penang Hospital, Malaysia.

Background: The aim of the present study was to evaluate the efficacy of mycophenolate mofetil in the induction therapy of proliferative lupus nephritis.

Methods: Forty-four patients from eight centres with newly diagnosed lupus nephritis World Health Organization class III or IV were randomly assigned to either mycophenolate mofetil (MMF) 2 g/day for 6 months or intravenous cyclophosphamide (IVC) 0.75-1 g/m(2) monthly for 6 months in addition to corticosteroids.

Results: Remission occurred in 13 out of 25 patients (52%) in the IVC group and 11 out of 19 patients (58%) in the MMF group (P = 0.70). There were 12% in the IVC group and 26% in the MMF group that achieved complete remission (P = 0.22). Improvements in haemoglobin, the erythrocyte sedimentation rate, serum albumin, serum complement, proteinuria, urinary activity, renal function and the Systemic Lupus Erythematosus Disease Activity Index score were similar in both groups. Twenty-four follow-up renal biopsies at the end of therapy showed a significant reduction in the activity score in both groups. The chronicity index increased in both groups but was only significant in the IVC group. Adverse events were similar. Major infections occurred in three patients in each group. There was no difference in gastrointestinal side-effects.

Conclusions: MMF in combination with corticosteroids is an effective induction therapy for moderately severe proliferative lupus nephritis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/j.1440-1797.2005.00444.xDOI Listing
October 2005

Prevention of renal failure: the Malaysian experience.

Kidney Int Suppl 2005 Apr(94):S70-4

Department of Medicine, Sultanah Aminah Hospital Johor Baru, Johor, Malaysia.

Renal replacement therapy in Malaysia has shown exponential growth since 1990. The dialysis acceptance rate for 2003 was 80 per million population, prevalence 391 per million population. There are now more than 10,000 patients on dialysis. This growth is proportional to the growth in gross domestic product (GDP). Improvement in nephrology and urology services with widespread availability of ultrasonography and renal pathology has improved care of renal patients. Proper management of renal stone disease, lupus nephritis, and acute renal failure has decreased these as causes of end-stage renal disease (ESRD) in younger age groups. Older patients are being accepted for dialysis, and 51% of new patients on dialysis were diabetic in 2003. The prevalence of diabetes is rising in the country (presently 7%); glycemic control of such patients is suboptimal. Thirty-three percent of adult Malaysians are hypertensive and blood pressure control is poor (6%). There is a national coordinating committee to oversee the control of diabetes and hypertension in the country. Primary care clinics have been provided with kits to detect microalbuminuria, and ACE inhibitors for the treatment of hypertension and diabetic nephropathy. Prevention of renal failure workshops targeted at primary care doctors have been launched, opportunistic screening at health clinics is being carried out, and public education targeting high-risk groups is ongoing. The challenge in Malaysia is to stem the rising tide of diabetic ESRD.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/j.1523-1755.2005.09418.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7112354PMC
April 2005