Publications by authors named "Fiorenza Ferrari"

42 Publications

The Role of Perfluorinated Compound Pollution in the Development of Acute and Chronic Kidney Disease.

Contrib Nephrol 2021 Aug 4;199:1-12. Epub 2021 Aug 4.

International Renal Research Institute of Vicenza (IRRIV), San Bortolo Hospital, Vicenza, Italy.

Clinical Background: Poly- and perfluorinated compound (PFCS) pollution has been found to be the driver of different diseases, including glucose intolerance, hyperlipidemia, thyroid diseases, gestational diabetes mellitus and hypertension, testicular and genitourinary cancer, as well as impaired kidney function. This review focuses on the renal effects of PFCS, intending to clarify their occurrence and pathogenetic mechanisms. Epidemiology: Between October 31st, 2017, and March 31st, 2020, most frequently analyzed PFCS were perfluorooctane sulfonate, perfluorooctanoic acid, sodium perfluoro-1-hexanesulfonate, perfluoro-n-nonanoic acid, and perfluoro-n-decanoic acid. Unfortunately, the novel replacement compounds (e.g., perfluoroether carboxylic acid) are unregulated, and they are not under study. PFCS are linked with an impaired kidney function: the kidney is a target of PFCS because it is involved in their excretion. Inter- and intra-species variations exist and affect PFCS pharmacokinetics, leading to different risk profiles of adverse effects, even at similar exposures, and influencing the risk of renal damage in case of concomitant exposure to PFCS and some heavy metals. Challenges, Prevention and Treatment: In the last 20 years, much effort has been made to stop the PFCS production in Europe and USA. However, human exposure remains persistently high due to PFCS long half-life, the large-scale production in some countries and the unregulated novel compounds. This context makes further studies mandatory to understand the pathogenetic mechanisms of old and new PFCS and the effective strategies to remove PFCS from the human blood in the most affected areas of the world.
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http://dx.doi.org/10.1159/000517711DOI Listing
August 2021

Renal Outcomes of Dialysis-Dependent Acute Kidney Injury in Noncritically Ill Patients: A Retrospective Study.

Blood Purif 2021 Jul 28:1-7. Epub 2021 Jul 28.

Unit of Nephrology, Dialysis and Transplantation, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.

Introduction: Acute kidney injury (AKI) is a common complication among hospitalized patients, potentially affecting short- and long-term clinical outcomes. In this retrospective study, we evaluated renal outcomes in noncritically ill patients who required acute hemodialysis (HD) because of an AKI episode occurring during hospitalization.

Methods: Sixty-three hemodynamically stable patients with AKI undergoing acute intermittent HD were included. Kidney function was evaluated at baseline control (pre-AKI), at AKI diagnosis and during the follow-up. According to serum creatinine and the estimated glomerular filtration rate (eGFR), we defined three clinical conditions: renal recovery, different stages of acute kidney disease (AKD), and chronic kidney disease (CKD).

Results: Among the 63 patients evaluated, 34 patients (54%) had a history of CKD. Six patients (10%) presented early full renal recovery. HD treatment was stopped in 38 patients (60%), while 25 patients (40%) required maintenance HD. Dialysis-independent patients presented lower comorbidity and higher baseline eGFR and delta creatinine, compared to dialysis-dependent patients. Baseline CKD, previous AKI episodes, and parenchymal causes of AKI were associated with a significant risk of dialysis dependence. At 1-month control, 15 patients (39%) presented AKD stage 0, 6 patients (16%) AKD stage 1, and 17 patients (44%) AKD stage 2-3. At 3-month control, 29 out of 38 patients recovering from AKI (76%) presented CKD. AKD stage was significantly correlated with the risk of CKD development, which, resulted higher in patients with lower baseline eGFR.

Conclusions: AKI might represent a risk factor for the development of chronic kidney damage, even in noncritically ill patients.
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http://dx.doi.org/10.1159/000517707DOI Listing
July 2021

Vancomycin concentrations during cardiopulmonary bypass in pediatric cardiac surgery: a prospective study.

Perfusion 2021 Mar 31:2676591211006828. Epub 2021 Mar 31.

Azienda Ospedaliero Universitaria Meyer, Firenze, Italy.

Introduction: Few data are available regarding intraoperative plasma concentrations of vancomycin administered as prophylaxis in pediatric cardiac surgery. The aims of this study were to investigate during pediatric cardiac surgery with cardiopulmonary bypass(CPB) the attainment of the area-under-the-curve of the vancomycin serum concentrations versus time over surgery to minimum inhibitory concentration ratio(AUC/MIC) of 400 (mg × h)/l and/or a target concentration of 15-20 mg/l.

Methods: In a prospective study, 40 patients divided into four subgroups (neonates, infants, children <10 years-old, ⩾10 years-old) undergoing cardiac surgery with cardiopulmonary bypass (CPB) were enrolled. A slow vancomycin bolus of 20 mg/kg, up to a maximum dose of 1000 mg was administered before skin incision and a further dose of 10 mg/kg (up to 500 mg) at CPB start. Vancomycin samples were collected intraoperatively at four time points.

Results: The median (interquartile range) age was 241.5 days (47-3898) and the median weight was 7.1 kg (3.1-37). The median AUC/MIC was 254.73 (165.89-508.06). In 11 patients the AUC/MIC target was not reached. Neonates displayed the lowest AUC/MIC values, and these were significantly lower than those of children ⩾10 years old (p = 0.02). Vancomycin concentrations were above the maximal target of 20 mg/l in 82.5% and 80% of patients at surgery and CPB start, respectively. At CPB and surgery end, 42.5% of patients showed vancomycin concentrations above 20 mg/l and 42.5% below 15 mg/l. Patients⩾10 years old showed the highest peak values whereas neonates were those with the lowest troughs. AUC/MIC correlated with age(r:0.36, p = 0.02), weight(r:0.35, p = 0.03), intraoperative protein value(r:0.40, p = 0.01), CPB priming volume/kg(r:-0.33, p = 0.04), CPB duration(r:0.36, p = 0.02) and vancomycin troughs(r:0.35, p = 0.04).

Conclusions: An AUC/MIC ⩾400 target was not reached in one-quarter of children undergoing heart surgery. Vancomycin peaked before the start of surgery and neonates were those with the lowest troughs. Vancomycin concentrations are affected by CPB hemodilution and by patients' age and weight.
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http://dx.doi.org/10.1177/02676591211006828DOI Listing
March 2021

Mechanical Power during Veno-Venous Extracorporeal Membrane Oxygenation Initiation: A Pilot-Study.

Membranes (Basel) 2021 Jan 2;11(1). Epub 2021 Jan 2.

Department of Cardio-Thoracic Surgery, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC), 6229 HX Maastricht, The Netherlands.

Mechanical power (MP) represents a useful parameter to describe and quantify the forces applied to the lungs during mechanical ventilation (MV). In this multi-center, prospective, observational study, we analyzed MP variations following MV adjustments after veno-venous extra-corporeal membrane oxygenation (VV ECMO) initiation. We also investigated whether the MV parameters (including MP) in the early phases of VV ECMO run may be related to the intensive care unit (ICU) mortality. Thirty-five patients with severe acute respiratory distress syndrome were prospectively enrolled and analyzed. After VV ECMO initiation, we observed a significant decrease in median MP (32.4 vs. 8.2 J/min, < 0.001), plateau pressure (27 vs. 21 cmHO, = 0.012), driving pressure (11 vs. 8 cmHO, = 0.014), respiratory rate (RR, 22 vs. 14 breaths/min, < 0.001), and tidal volume adjusted to patient ideal body weight (V/IBW, 5.5 vs. 4.0 mL/kg, = 0.001) values. During the early phase of ECMO run, RR (17 vs. 13 breaths/min, = 0.003) was significantly higher, while positive end-expiratory pressure (10 vs. 14 cmHO, = 0.048) and V/IBW (3.0 vs. 4.0 mL/kg, = 0.028) were lower in ICU non-survivors, when compared to the survivors. The observed decrease in MP after ECMO initiation did not influence ICU outcome. Waiting for large studies assessing the role of these parameters in VV ECMO patients, RR and MP monitoring should not be underrated during ECMO.
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http://dx.doi.org/10.3390/membranes11010030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824596PMC
January 2021

Immunoglobulin deficiency as an indicator of disease severity in patients with COVID-19.

Am J Physiol Lung Cell Mol Physiol 2021 04 25;320(4):L590-L599. Epub 2020 Nov 25.

Department of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany.

Despite the pandemic status of COVID-19, there is limited information about host risk factors and treatment beyond supportive care. Immunoglobulin G (IgG) could be a potential treatment target. Our aim was to determine the incidence of IgG deficiency and associated risk factors in a cohort of 62 critically ill patients with COVID-19 admitted to two German ICUs (72.6% male, median age: 61 yr). Thirteen (21.0%) of the patients displayed IgG deficiency (IgG < 7 g/L) at baseline (predominant for the IgG1, IgG2, and IgG4 subclasses). Patients who were IgG-deficient had worse measures of clinical disease severity than those with normal IgG levels (shorter duration from disease onset to ICU admission, lower ratio of [Formula: see text] to [Formula: see text], higher Sequential Organ Failure Assessment score, and higher levels of ferritin, neutrophil-to-lymphocyte ratio, and serum creatinine). Patients who were IgG-deficient were also more likely to have sustained lower levels of lymphocyte counts and higher levels of ferritin throughout the hospital stay. Furthermore, patients who were IgG-deficient compared with those with normal IgG levels displayed higher rates of acute kidney injury (76.9% vs. 26.5%; = 0.001) and death (46.2% vs. 14.3%; = 0.012), longer ICU [28 (6-48) vs. 12 (3-18) days; = 0.012] and hospital length of stay [30 (22-50) vs. 18 (9-24) days; = 0.004]. Univariable logistic regression showed increasing odds of 90-day overall mortality associated with IgG-deficiency (odds ratio 5.14, 95% confidence interval 1.3-19.9; = 0.018). IgG deficiency might be common in patients with COVID-19 who are critically ill, and warrants investigation as both a marker of disease severity as well as a potential therapeutic target.
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http://dx.doi.org/10.1152/ajplung.00359.2020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8057306PMC
April 2021

Hemoperfusion with CytoSorb as Adjuvant Therapy in Critically Ill Patients with SARS-CoV2 Pneumonia.

Blood Purif 2021;50(4-5):566-571. Epub 2020 Nov 12.

Department of Anaesthesia and Intensive Care Unit, Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy.

We report a preliminary experience of adjuvant therapy with Hemoperfusion (HP) in patients with Severe Acute Respiratory Syndrome-CoronaVirus 2 (SARS-CoV2) pneumonia. Currently, there are no approved treatments for CoronaVirus Disease 19 (COVID-19); however, therapeutic strategies based on the preclinical evidence include supportive measures, such as oxygen supplementation, antiviral, and anticoagulant agents. Despite these treatments, 10% of patients worsen and develop severe acute respiratory distress syndrome (ARDS). Since the pathogenic mechanism of ARDS is an uncontrolled inflammatory state, we speculate that removing inflammation effectors from blood may contrast tissue injury and improve clinical outcome. In a scenario of dramatic medical emergency, we conducted an observational study on 9 consecutive patients hospitalized in COVID Intensive Care Unit, where 5 of 9 consecutive patients were treated with HP, due to the emergency overload made it impossible to deliver blood purification in the other 4 patients. COVID-19 was diagnosed through the identification of virus sequences by reverse transcription-PCR on respiratory specimens. All patients had severe pneumonia requiring continuous positive airway pressure. HP was started in all patients 6-7 days after hospital admission. The treated patients (T) received 2 consecutive sessions of HP using CytoSorb cartridge. Our results show a better clinical course of T compared to control patients (C), in fact all T except 1 survived, and only 2 of them were intubated, while all C required intubation and died. Lymphocytopenia worsened in C but not in T. C-reactive protein decreased in both patients, but to a greater extent in T. IL-6, IL-8, and TNF-α decreased after HP, IL-10 did not change. Respiratory function remained stable and did not worsen in T compared to C. The limited sample size and observational study design preclude a sound statement about the potential effectiveness of HP in COVID-19 patients, but our experience suggests a potential therapeutic role of adjuvant CytoSorb HP in the early course of CO-VID-19 pneumonia. A randomized clinical trial is ongoing.
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http://dx.doi.org/10.1159/000511725DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7705939PMC
July 2021

Carbon Dioxide Elimination During Veno-Venous Extracorporeal Membrane Oxygenation Weaning: A Pilot Study.

ASAIO J 2021 06;67(6):700-708

Department of Cardio-Thoracic Surgery, Heart & Vascular Centre, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Hospital, Maastricht, The Netherlands.

Veno-venous extracorporeal membrane oxygenation (V-V ECMO) represents a component of the treatment strategy for severe respiratory failure. Clinical evidence on the management of the lung during V-V ECMO are limited just as the consensus regarding timing of weaning. The monitoring of the carbon dioxide (CO2) removal (V'CO2TOT) is subdivided into two components: the membrane lung (ML) and the native lung (NL) are both taken into consideration to evaluate the improvement of the function of the lung and to predict the time to wean off ECMO. We enrolled patients with acute respiratory distress syndrome (ARDS). The V'CO2NL ratio (V'CO2NL/V'CO2TOT) value was calculated based on the distribution of CO2 between the NL and the ML. Of 18 patients, 15 were successfully weaned off of V-V ECMO. In this subgroup, we observed a significant increase in the V'CO2NL ratio comparing the median values of the first and last quartiles (0.32 vs. 0.53, p = 0.0045), without observing any modifications in the ventilation parameters. An increase in the V'CO2NL ratio, independently from any change in ventilation could, despite the limitations of the study, indicate an improvement in pulmonary function and may be used as a weaning index for ECMO.
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http://dx.doi.org/10.1097/MAT.0000000000001282DOI Listing
June 2021

Blood purification therapy with a hemodiafilter featuring enhanced adsorptive properties for cytokine removal in patients presenting COVID-19: a pilot study.

Crit Care 2020 10 12;24(1):605. Epub 2020 Oct 12.

International Renal Research Institute of Vicenza (IRRIV), Vicenza, Italy.

Background: Systemic inflammation in COVID-19 often leads to multiple organ failure, including acute kidney injury (AKI). Renal replacement therapy (RRT) in combination with sequential extracorporeal blood purification therapies (EBP) might support renal function, attenuate systemic inflammation, and prevent or mitigate multiple organ dysfunctions in COVID-19.

Aim: Describe overtime variations of clinical and biochemical features of critically ill patients with COVID-19 treated with EBP with a hemodiafilter characterized by enhanced cytokine adsorption properties.

Methods: An observational prospective study assessing the outcome of patients with COVID-19 admitted to the ICU (February to April 2020) treated with EBP according to local practice. Main endpoints included overtime variation of IL-6 and multiorgan function-scores, mortality, and occurrence of technical complications or adverse events.

Results: The study evaluated 37 patients. Median baseline IL-6 was 1230 pg/ml (IQR 895) and decreased overtime (p < 0.001 Kruskal-Wallis test) during the first 72 h of the treatment, with the most significant decrease in the first 24 h (p = 0.001). The reduction in serum IL-6 concentrations correlated with the improvement in organ function, as measured in the decrease of SOFA score (rho = 0.48, p = 0.0003). Median baseline SOFA was 13 (IQR 6) and decreased significantly overtime (p < 0.001 at Kruskal-Wallis test) during the first 72 h of the treatment, with the most significant decrease in the first 48 h (median 8 IQR 5, p = 0.001). Compared to the expected mortality rates, as calculated by APACHE IV, the mean observed rates were 8.3% lower after treatment. The best improvement in mortality rate was observed in patients receiving EBP early on during the ICU stay. Premature clotting (running < 24 h) occurred in patients (18.9% of total) which featured higher effluent dose (median 33.6 ml/kg/h, IQR 9) and higher filtration fraction (median 31%, IQR 7.4). No electrolyte disorders, catheter displacement, circuit disconnection, unexpected bleeding, air, or thromboembolisms due to venous cannulation of EBP were recorded during the treatment. In one case, infection of vascular access occurred during RRT, requiring replacement.

Conclusions: EBP with heparin-coated hemodiafilter featuring cytokine adsorption properties administered to patients with COVID-19 showed to be feasible and with no adverse events. During the treatment, patients experienced serum IL-6 level reduction, attenuation of systemic inflammation, multiorgan dysfunction improvement, and reduction in expected ICU mortality rate.
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http://dx.doi.org/10.1186/s13054-020-03322-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7549343PMC
October 2020

Coronavirus disease 2019 in critically ill patients: can we re-program the immune system? A primer for Intensivists.

Minerva Anestesiol 2020 11 4;86(11):1214-1233. Epub 2020 Aug 4.

Department of Nephrology, Dialysis and Transplantation, International Renal Research Institute of Vicenza (IRRIV), Vicenza, Italy.

In December 2019, Coronavirus disease 2019 (COVID-19) emerged in Wuhan and rapidly spread around the word. The immune response is essential to control and eliminate CoV infections, however, multiorgan damage might be due to direct SARS-CoV2 action against the infected organ cells, as well as an imbalanced host immune response. In effect, a "cytokines storm" and an impaired innate immunity were found in the COVID-19 critically ill patients. In this review, we summarized the virus immune response steps, underlying the relevance of introducing the measurement of plasma cytokine levels and of circulating lymphocyte subsets in clinical practice for the follow-up of critically ill COVID-19 patients and support new therapy.
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http://dx.doi.org/10.23736/S0375-9393.20.14663-7DOI Listing
November 2020

Clinical and Operative Determinants of Acute Kidney Injury after Cardiac Surgery.

Cardiorenal Med 2020 29;10(5):340-352. Epub 2020 Jun 29.

International Renal Research Institute of Vicenza, Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza, Italy.

Introduction: Cardiac surgery-associated acute kidney injury (CSA-AKI) is associated with increased morbidity and mortality.

Objectives: We aimed to identify potentially modifiable risk factors for CSA-AKI.

Methods: This was asingle-center retrospective cohort study of 495 adult patients undergoing cardiac surgery. AKI was diagnosed and staged using full KDIGO criteria incorporating baseline serum creatinine (SC) levels and correction of postoperative SC levels for fluid balance. We examined the association of routinely available clinical and laboratory data with AKI using multivariate logistic regression modeling.

Results: A total of 103 (20.8%) patients developed AKI: 16 (15.5%) patients were diagnosed with AKI upon hospital admission, and 87 (84.5%) patients were diagnosed with CSA-AKI. Correction of SC levels for fluid balance increased the number of AKI cases to 104 (21.0%), with 6 patients categorized to different AKI stages. Univariate logistic regression analysis identified five preoperative (age, sex, diabetes mellitus, preoperative systolic pulmonary arterial pressure [PSPAP], acute decompensated heart failure) and five intraoperative predictors of AKI (age, sex, red blood cell [RBC] volume transfused, use of minimally invasive surgery, duration of cardiopulmonary bypass). When all preoperative and intraoperative variables were incorporated into one model, six predictors remained significant (age, sex, use of minimally invasive surgery, RBC volume transfused, PSPAP, duration of cardiopulmonary bypass). Model discrimination performance showed an area under the curve of 0.69 for the model including only preoperative variables, 0.76 for the model including only intraoperative variables, and 0.77 for the model including all preoperative and intraoperative variables.

Conclusions: Use of minimally invasive surgery and therapies mitigating PSPAP and intraoperative blood loss may offer protection against CSA-AKI.
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http://dx.doi.org/10.1159/000507777DOI Listing
August 2021

Pre-transplant renal functional reserve and renal function after lung transplantation.

J Heart Lung Transplant 2020 09 26;39(9):970-974. Epub 2020 May 26.

Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine II, University Hospital Giessen and Marburg, Giessen, Germany; German Centre for Lung Research (DZL), Universities of Giessen and Marburg Lung Centre (UGMLC), Giessen, Germany; Department of Pulmonology and Sleep Medicine, St. Vincentius-Clinics, Karlsruhe, Germany.

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http://dx.doi.org/10.1016/j.healun.2020.05.011DOI Listing
September 2020

Neutrophil gelatinase-associated lipocalin does not predict acute kidney injury in heart failure.

World J Clin Cases 2020 May;8(9):1600-1607

Department of Nephrology Dialysis & Transplantation, International Renal Research Institute Vicenza, St. Bortolo Hospital, Vicenza 36100, Italy.

Background: Acute cardiorenal syndrome type 1 (CRS-1) is defined by a rapid cardiac dysfunction leading to acute kidney injury (AKI). Neutrophil gelatinase-associated lipocalin (NGAL) is expressed on the surface of human neutrophils and epithelial cells, such as renal tubule cells, and its serum (sNGAL) and urinary have been used to predict AKI in different clinical settings.

Aim: To characterize CRS-1 in a cohort of patients with acute heart diseases, evaluating the potentiality of sNGAL as an early marker of CRS-1.

Methods: We performed a retrospective cohort, multi-centre study. From January 2010 to December 2011, we recruited 202 adult patients admitted to the coronary intensive care unit (CICU) with a diagnosis of acute heart failure or acute coronary syndrome. We monitored the renal function to evaluate CRS-1 development and measured sNGAL levels within 24 h and after 72 h of CICU admission.

Results: Overall, enrolled patients were hemodynamically stable with a mean arterial pressure of 92 (82-107) mmHg, 55/202 (27.2%) of the patients developed CRS-1, but none of them required dialysis. Neither the NGAL delta value (AUC 0.40, 95%CI: 0.25-0.55) nor the NGAL peak (AUC 0.45, 95%CI: 0.36-0.54) or NGAL cut-off (≥ 140 ng/mL) values were statistically significant between the two groups (CRS-1 no-CRS1 patients). The area under the ROC curve for the prediction of CRS-1 was 0.40 (95%CI: 0.25-0.55) for the delta NGAL value and 0.45 (95%CI: 0.36-0.54) for the NGAL peak value. Finally, in multivariate analysis, the risk of developing CRS-1 was correlated with age > 60 years, urea nitrogen at admission and 24 h-urine output (AUC 0.83, SE = 60.5% SP = 93%), while sNGAL was not significantly correlated.

Conclusion: In our population, sNGAL does not predict CRS-1, probably as a consequence of the mild renal injury and the low severity of heart disease. So, these data might suggest that patient selection should be taken into account when considering the utility of NGAL measurement as a biomarker of kidney damage.
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http://dx.doi.org/10.12998/wjcc.v8.i9.1600DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7211536PMC
May 2020

Validation of a simple and economic HPLC-UV method for the simultaneous determination of vancomycin, meropenem, piperacillin and tazobactam in plasma samples.

J Chromatogr B Analyt Technol Biomed Life Sci 2020 May 11;1148:122151. Epub 2020 May 11.

Department of Drug Science and Technology, University of Turin, Via P. Giuria 9, I-10125 Turin, Italy. Electronic address:

Critically ill patients are often affected by several pathophysiological conditions requiring antibiotic administration and, frequently, extracorporeal therapy that significantly alter the normal pharmacokinetics of drugs. Therapeutic drug monitoring (TDM) may assist to establish the correct antibiotic dosage, but a TDM service is usually available only for some aminoglycosides and glycopeptides. The aim of this study is the validation of an HPLC-UV method for the simultaneous quantification of meropenem, vancomycin, piperacillin and tazobactam in human plasma samples. The analytes were extracted from 250 μL of human plasma by the addition of acetonitrile for protein precipitation. After evaporation to dryness of the solvent, samples were reconstituted with 250 μL of mobile phase, and 100 μL were injected in HPLC. Chromatographic analysis was performed using a Kinetex C18 column and an UV/Vis detector set at 220 and 298 nm. The mobile phase was a mixture of phosphate buffer 0.1 M pH 3.15 and methanol in gradient, delivered at 1 mL/min. The method was validated over clinical concentration ranges. For all the analytes, the lower limit of quantification was 1 μg/mL, and the calibration curves were linear between 1 and 100 μg/mL, with coefficients of determination ≥ 0.999. Intra-day precision was < 4%, while inter-day precision was < 7% for each analyte. The applicability of the method has been evaluated by analysing plasma samples collected from 4 critically ill patients undergoing continuous renal replacement therapy. Moreover, the analysis of vancomycin with VANC Flex® confirmed a good correlation between the results of HPLC-UV and commercially available kits usually used by TDM service. The method we developed only requires a small volume of plasma and uses the same sample preparation protocol, stationary phase and elution conditions for all analytes. This method offers the additional advantages of simple and rather inexpensive sample preparation and instrumentation, features that make this method an easy implementation for a general TDM laboratory.
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http://dx.doi.org/10.1016/j.jchromb.2020.122151DOI Listing
May 2020

Preemptive kidney support: an optimal practice or a good theory?

Ann Transl Med 2020 Apr;8(7):422

Department of Health Science, section of Anesthesiology and Intensive Care, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.

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http://dx.doi.org/10.21037/atm.2020.03.96DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7210137PMC
April 2020

Population Pharmacokinetics of Cefoxitin Administered for Pediatric Cardiac Surgery Prophylaxis.

Pediatr Infect Dis J 2020 07;39(7):609-614

Department of Drug Science and Technology, University of Turin, Turin, Italy.

Background: Available data about pharmacokinetics (PK) of antimicrobials administered as surgical prophylaxis to children undergoing cardiac surgery with cardiopulmonary bypass (CPB) showed that drug concentrations during CPB may be supra or subtherapeutic. The aim of this study was to determine the population PK and pharmacodynamic target attainment (PTA) of cefoxitin during pediatric CPB surgery.

Methods: A prospective interventional study was conducted. Cefoxitin (40 mg/kg, up to max 1000 mg) was administered before skin incision. Blood samples were obtained in the operatory room throughout surgery. Population PK, PTA, and safety of cefoxitin were evaluated in neonates, infants, children <10 and >10 years old.

Results: Forty patients were enrolled. Cefoxitin levels correlated with time from bolus administration (r = -0.6, P = 0.0001) and, after 240 minutes from bolus, drug values below the target (8 mg/L) were shown. Cefoxitin concentrations were best described by a one-compartment model with first order elimination. A significant relationship was identified between body weight, age, body mass index, and serum creatinine on drug clearance and age, body weight, and body mass index on cefoxitin volume of distribution. The PTA for free drug concentration being above the minimum inhibitory concentration of 8 mg/L for at least 240 minutes was >90% in all age groups except in patients >10 years of age (PTA = 62%).

Conclusions: Cefoxitin PK appears to be significantly influenced by CPB with generally reduced drug clearance. The PTA was adequately achieved in the majority of patients except in patients >10 years old or longer surgeries.
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http://dx.doi.org/10.1097/INF.0000000000002635DOI Listing
July 2020

Brief Report: A Case of Tramadol Overdose: Extracorporeal Life Support and Hemoperfusion as Life-Saving Treatment.

Blood Purif 2020 4;49(4):509-512. Epub 2020 Feb 4.

Department of Anaesthesia and Intensive Care Unit, I.R.C.C.S. San Matteo Hospital and University of Pavia, Pavia, Italy.

We describe the case of a 49-year-old woman with a Tramadol intoxication associated with multiorgan failure. Veno-arterial femoro-femoral extracorporeal life support (VA-ECLS) and hemoperfusion (HP) were used as rescue treatments. The emergency medical service found a woman at home unconscious. Once in the hospital, she was intubated and catecholamines support was immediately started for a severe shock. Brain CT was normal, whereas EEG revealed a metabolic encephalopathy pattern. Toxic levels of Tramadol and Quetiapine were detected. VA-ECLS was implanted due to persistent multiorgan failure, and HP with a charcoal cartridge was set to increase the Tramadol clearance. To quantify the charcoal cartridge's removal efficiency of Tramadol, Tramadol concentration was measured before and after the cartridge and before and after the treatment in the patient's blood. The charcoal cartridge showed good extraction ratio during the treatment and no significant rebound effect. VA-ECLS and HP allowed the patient to be weaned from vasoconstrictors and the resolution of the organ failures. These treatments might be lifesaving in the Tramadol intoxication.
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http://dx.doi.org/10.1159/000505845DOI Listing
May 2021

Alterations in Doppler-derived renal venous stasis index during recompensation of right heart failure and fluid overload in a patient with pulmonary hypertension.

Rev Cardiovasc Med 2019 Dec;20(4):263-266

Department of Internal Medicine II, Division of Pulmonology and Critical Care Medicine, University Hospital Giessen and Marburg, 35392, Giessen, Germany.

Renal congestion is becoming recognized as a potential contributor to cardiorenal syndromes. Adequate control of congestion with simultaneous preservation of renal function has been proposed as a central goal of the management of heart failure. We report our care of a 48-year-old woman suffering from right heart failure and massive fluid overload due to severe pulmonary hypertension secondary to a combination of left-heart disease and status after recurrent pulmonary embolisms. Alterations in Doppler-derived intrarenal venous flow patterns and a novel renal venous stasis index were used to evaluate improvement in renal venous congestion during recompensation. Due to refractory congestion despite optimal medical treatment and continuous veno-venous hemodialysis, a peritoneal dialysis catheter was placed to relieve the massive ascites. The paracentesis of ascites led to a significant loss of weight, normalization of hydration status with subsequent termination of continuous veno-venous hemodialysis, and a significant improvement in clinical and echocardiographic parameters. Renal Doppler ultrasonography showed continuous improvement in intrarenal venous flow patterns and the renal venous stasis index indicative of effective decongestion up to a normal intrarenal venous flow pattern and renal venous stasis index. Furthermore, residual renal function increased during follow-up. This case demonstrates the feasibility of renal Doppler ultrasonography as a simple, non-invasive, and integrative measure of renal congestion. The renal venous stasis index and intrarenal venous flow patterns may be useful to evaluate the treatment response and to guide therapy in patients with right heart failure.
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http://dx.doi.org/10.31083/j.rcm.2019.04.564DOI Listing
December 2019

Routine Adoption of Urinary [IGFBP7]∙[TIMP-2] to Assess Acute Kidney Injury at Any Stage 12 hours After Intensive Care Unit Admission: a Prospective Cohort Study.

Sci Rep 2019 11 11;9(1):16484. Epub 2019 Nov 11.

International Renal Research Institute of Vicenza (IRRIV) and Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Viale Rodolfi, 37- 36100, Vicenza, Italy.

The urinary tissue inhibitor of metalloproteinases-2 and insulin-like growth factor-binding protein 7 ([TIMP-2]∙[IGFBP7]) have been introduced to improve risk prediction of severe acute kidney injury (AKI) within 12 hours of measurement. We performed a prospective cohort study to evaluate if the predictive value of [TIMP-2]∙[IGFBP7] for AKI might continue after 12 hours. We enrolled 442 critically ill adult patients from June to December 2016. Urine samples were collected at admission for [TIMP-2]∙[IGFBP7] measurement. Baseline patient characteristics were recorded including patients' demographics, prior health history, and the main reason for admission to build a logistic regression model to predict AKI. AKI occurrence differed between patients with [TIMP-2]∙[IGFBP7] ≤0.3 and >0.3 (ng/ml)/1000 (31.9% and 68.10% respectively; p < 0.001). Patients with AKI had higher biomarker values compared to those without AKI (0.66 (0.21-2.84) vs 0.22 (0.08-0.63) (ng/ml)/1000; p < 0.001). [TIMP-2]∙[IGFBP7] at ICU admission had a lower performance in predicting AKI at any stage within 48 hours and 7 days after measurement (area under the receiver operating characteristic curve (AUC) equal to 0.70 (95%CI 0.65-0.76), AUC 0.68 (95%CI 0.63-0.73)). In the logistic regression model, 0.1 (ng/ml)/1000-unit increment was likely to increase the risk of AKI by 2% (p = 0.002).
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http://dx.doi.org/10.1038/s41598-019-52790-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6848119PMC
November 2019

Persistent pollutants: focus on perfluorinated compounds and kidney.

Curr Opin Crit Care 2019 12;25(6):539-549

International Renal Research Institute of Vicenza (IRRIV), San Bortolo Hospital, Vicenza.

Purpose Of Review: There is increasing interest in the environmental and human damage caused by pollutants. Big efforts are continuously made to monitor their levels and identify safe thresholds. For this purpose, an essential step is to prioritize harmful substances and understand their effect on human body. Perfluorinated compounds (PFCs) deserve particular attention because of their wide diffusion and potential correlation with different diseases including glucose intolerance, hyperlipidaemia, thyroid diseases, gestational diabetes mellitus and hypertension, testicular and genitourinary cancer as well as impaired kidney function. This review focuses on the renal effects of PFCs, with the attempt to clarify their occurrence and pathogenetic mechanisms.

Recent Findings: We reviewed MEDLINE and EMBASE citations between 31 October 2017 and 31 May 2019 and selected human studies measuring PFCs exposure, kidney function markers and the ability of haemodialysis to remove PFCs from the circulating blood. It has been currently clarified that exposure to PFCs is linked with an impaired kidney function and that they can be removed by blood purification.

Summary: Further studies are required on the potential synergic negative effect of PFCs co-exposure with other pollutants as well as animal studies about the removal capacity of different haemodialysis membranes.
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http://dx.doi.org/10.1097/MCC.0000000000000658DOI Listing
December 2019

An unusual view for veno-venous extra-corporeal membrane oxygenation cannulas visualization.

Intensive Care Med 2020 03 21;46(3):534-535. Epub 2019 Aug 21.

Anesthesia and Intensive Care, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Policlinico San Matteo, Pavia, Italy.

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http://dx.doi.org/10.1007/s00134-019-05745-4DOI Listing
March 2020

Development and validation of quick Acute Kidney Injury-score (q-AKI) to predict acute kidney injury at admission to a multidisciplinary intensive care unit.

PLoS One 2019 20;14(6):e0217424. Epub 2019 Jun 20.

International Renal Research Institute of Vicenza (IRRIV) and Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Viale Rodolfi, Vicenza, Italy.

AKI is associated with increased risk of death, prolonged length of stay and development of de-novo chronic kidney disease. The aim of our study is the development and validation of prediction models to identify the risk of AKI in ICU patients up to 7 days. We retrospectively recruited 692 consecutive patients admitted to the ICU at San Bortolo Hospital (Vicenza, Italy) from 1 June 2016 to 31 March 2017: 455 patients were treated as the derivation group and 237 as the validation group. Candidate variables were selected based on a literature review and expert opinion. Admission eGFR< 90 ml/min /1.73 mq (OR 2.78; 95% CI 1.78-4.35; p<0.001); SOFAcv ≥ 2 (OR 2.23; 95% CI 1.48-3.37; p<0.001); lactate ≥ 2 mmol/L (OR 1.81; 95% CI 1.19-2.74; p = 0.005) and (TIMP-2)•(IGFBP7) ≥ 0.3 (OR 1.65; 95% CI 1.08-2.52; p = 0.019) were significantly associated with AKI. For the q-AKI score, we stratified patients into different AKI Risk score levels: 0-2; 3-4; 5-6; 7-8 and 9-10. In both cohorts, we observed that the proportion of AKI patients was higher in the higher score levels.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0217424PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6586286PMC
February 2020

Tissue inhibitor metalloproteinase-2 (TIMP-2) • IGF-binding protein-7 (IGFBP7) levels are associated with adverse outcomes in patients in the intensive care unit with acute kidney injury.

Kidney Int 2019 06 9;95(6):1486-1493. Epub 2019 Mar 9.

International Renal Research Institute of Vicenza (IRRIV), San Bortolo Hospital, Vicenza, Italy; Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza, Italy; Department of Medicine, University of Padova, Padova, Italy.

The G1 cell cycle inhibitors tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor-binding protein 7 (IGFBP7) have been identified as novel biomarkers for the prediction of moderate to severe acute kidney injury (AKI) risk. However, the prognostic value of [TIMP-2]•[IGFBP7] in predicting adverse outcomes in intensive care unit (ICU) patients with AKI was not previously described. To evaluate this, we conducted a cohort study, measuring [TIMP2]•[IGFBP7] levels in critically ill patients admitted to the ICU and classified the patients as NephroCheck (NC) (+) or NC (-) according to [TIMP-2]•[IGFBP7] values and AKI (+) or AKI (-) according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. We then evaluated the incidence of continuous renal replacement therapy initiation, all-cause mortality and a composite endpoint of both in the four groups. Baseline [TIMP-2]•[IGFBP7] values were available for 719 patients, of whom 239 developed AKI and 151 met the composite endpoint. Compared to NC (-)/AKI (+) patients, NC (+)/AKI (+) patients had a significant risk of ICU mortality and the composite endpoint. Kaplan-Meier curves showed that the survival estimate for the composite endpoint of NC (+)/AKI (+) patients was 34.4%; significantly worse than NC (-)/AKI (+) patients (67.4%). Multivariate analyses showed strong association between NC positivity and the composite endpoint. The inflammatory marker, procalcitonin, was an additional prognostic biomarker to compare and confirm the incremental value of NephroCheck. No association between procalcitonin and the composite endpoint was found, especially in patients with AKI, suggesting that NephroCheck may be more kidney specific. Thus, the [TIMP-2]•[IGFBP7] values can serve to identify patients with AKI at increased risk for adverse outcomes in the ICU.
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http://dx.doi.org/10.1016/j.kint.2019.01.020DOI Listing
June 2019

Persistent decrease of renal functional reserve in patients after cardiac surgery-associated acute kidney injury despite clinical recovery.

Nephrol Dial Transplant 2019 02;34(2):308-317

International Renal Research Institute of Vicenza, San Bortolo Hospital, Vicenza, Italy.

Background: Cardiac surgery is a leading cause of acute kidney injury (AKI). Such AKI patients may develop progressive chronic kidney disease (CKD). Others, who appear to have sustained no permanent loss of function (normal serum creatinine), may still lose renal functional reserve (RFR).

Methods: We extended the follow-up in the observational 'Preoperative RFR Predicts Risk of AKI after Cardiac Surgery' study from hospital discharge to 3 months after surgery for 86 (78.2%) patients with normal baseline estimated glomerular filtration rate (eGFR), and re-measured RFR with a high oral protein load. The primary study endpoint was change in RFR. Study registration at clinicaltrials.gov Identifier: NCT03092947, ISRCTN Registry: ISRCTN16109759.

Results: At 3 months, three patients developed new CKD. All remaining patients continued to have a normal eGFR (93.3 ± 15.1 mL/min/1.73 m2). However, when stratified by post-operative AKI and cell cycle arrest (CCA) biomarkers, AKI patients displayed a significant decrease in RFR {from 14.4 [interquartile range (IQR) 9.5 - 24.3] to 9.1 (IQR 7.1 - 12.5) mL/min/1.73 m2; P < 0.001} and patients without AKI but with positive post-operative CCA biomarkers also experienced a similar decrease of RFR [from 26.7 (IQR 22.9 - 31.5) to 19.7 (IQR 15.8 - 22.8) mL/min/1.73 m2; P < 0.001]. In contrast, patients with neither clinical AKI nor positive biomarkers had no such decrease of RFR. Finally, of the three patients who developed new CKD, two sustained AKI and one had positive CCA biomarkers but without AKI.

Conclusions: Among elective cardiac surgery patients, AKI or elevated post-operative CCA biomarkers were associated with decreased RFR at 3 months despite normalization of serum creatinine. Larger prospective studies to validate the use of RFR to assess renal recovery in combination with biochemical biomarkers are warranted.
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http://dx.doi.org/10.1093/ndt/gfy227DOI Listing
February 2019

Discontinuation of Continuous Renal Replacement Therapy and Dialysis Dependence.

Contrib Nephrol 2018 29;194:118-125. Epub 2018 Mar 29.

Renal replacement therapy (RRT) is a form of extracorporeal support for critical patients, especially for those with acute kidney injury. This therapy enables to gain adequate control over the great metabolic and fluids demand when kidneys are not able to do so; this condition is habitually present in patients who are admitted to intensive care units. However, it is also clear that these patients present a higher mortality rate and, in some cases, complications associated with the therapy. Therefore, it is fundamental to optimize and customize different aspects of RRT that range from the ideal timing including the modality and the dose until its suspension or ending. There currently is a great deal of controversy in all of these RRT-related topics. Although different predictive models have been proposed to determine the optimal timing of therapy discontinuation, nowadays urine output, serum and urine creatinine levels are perhaps the only variables associated with effective discontinuation. Future studies should focus on more accurately predicting renal recovery. This review provides an approach based on current evidence regarding effective discontinuation.
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http://dx.doi.org/10.1159/000485609DOI Listing
April 2019

Predicting Acute Kidney Injury in Intensive Care Unit Patients: The Role of Tissue Inhibitor of Metalloproteinases-2 and Insulin-Like Growth Factor-Binding Protein-7 Biomarkers.

Blood Purif 2018 26;45(1-3):270-277. Epub 2018 Jan 26.

International Renal Research Institute of Vicenza, San Bortolo Hospital, Vicenza, Italy.

Background: Acute kidney injury (AKI) diagnosis is based on a rise in serum creatinine and/or fall in urine output. It has been shown that there are patients that fulfill AKI definition but do not have AKI, and there are also patients with evidence of renal injury who do not meet any criteria for AKI. Recently the innovative and emerging proteomic technology has enabled the identification of novel biomarkers that allow improved risk stratification.

Methods: Tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor-binding protein 7 (IGFBP7) were measured to a cohort of 719 consecutive patients admitted to Intensive Care Unit (ICU). The primary endpoint was the evaluation of clinical performances of the biomarkers focusing on the probability do develop AKI in the first 7 days.

Results: The Kaplan-Meier analysis considering the first 7 days of ICU stay suggested a lower risk of developing AKI (p < 0.0001) for patients with a negative (<0.3; TIMP-2*IGFBP7) test.

Conclusion: (TIMP-2*IGFBP7) at ICU admission has a good performance in predicting AKI, especially in the first 4 days in ICU.
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http://dx.doi.org/10.1159/000485591DOI Listing
February 2019

Preoperative Renal Functional Reserve Predicts Risk of Acute Kidney Injury After Cardiac Operation.

Ann Thorac Surg 2018 04 31;105(4):1094-1101. Epub 2018 Jan 31.

International Renal Research Institute of Vicenza, San Bortolo Hospital, Vicenza, Italy; Department of Nephrology, Dialysis and Transplantation, San Bortolo Hospital, Vicenza, Italy. Electronic address:

Background: Although acute kidney injury (AKI) frequently complicates cardiac operations, methods to determine AKI risk in patients without underlying kidney disease are lacking. Renal functional reserve (RFR) can be used to measure the capacity of the kidney to increase glomerular filtration rate under conditions of physiologic stress and may serve as a functional marker that assesses susceptibility to injury. We sought to determine whether preoperative RFR predicts postoperative AKI.

Methods: We enrolled 110 patients with normal resting glomerular filtration rates undergoing elective cardiac operation. Preoperative RFR was measured by using a high oral protein load test. The primary end point was the ability of preoperative RFR to predict AKI within 7 days of operation. Secondary end points included the ability of a risk prediction model, including demographic and comorbidity covariates, RFR, and intraoperative variables to predict AKI, and the ability of postoperative cell cycle arrest markers at various times to predict AKI.

Results: AKI occurred in 15 patients (13.6%). Preoperative RFR was lower in patients who experienced AKI (p < 0.001) and predicted AKI with an area under the receiver operating characteristic curve (AUC) of 0.83 (95% confidence interval [CI]: 0.70 to 0.96). Patients with preoperative RFRs not greater than 15 mL · min · 1.73 m were 11.8 times more likely to experience AKI (95% CI: 4.62 to 29.89 times, p < 0.001). In addition, immediate postoperative cell cycle arrest biomarkers predicted AKI with an AUC of 0.87.

Conclusions: Among elective cardiac surgical patients with normal resting glomerular filtration rates, preoperative RFR was highly predictive of AKI. A reduced RFR appears to be a novel risk factor for AKI, and measurement of RFR preoperatively can identify patients who are likely to benefit from preventive measures or to select for use of biomarkers for early detection. Larger prospective studies to validate the use of RFR in strategies to prevent AKI are warranted. ClinicalTrials.gov identifier: NCT03092947, ISRCTN Registry: ISRCTN16109759.
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http://dx.doi.org/10.1016/j.athoracsur.2017.12.034DOI Listing
April 2018

Routine adoption of TIMP2 and IGFBP7 biomarkers in cardiac surgery for early identification of acute kidney injury.

Int J Artif Organs 2017 Nov 16;40(12):714-718. Epub 2017 Nov 16.

International Renal Research Institute of Vicenza, San Bortolo Hospital, Vicenza - Italy.

Background And Purpose: Acute Kidney Injury (AKI) is a severe complication affecting many hospitalized patients after cardiac surgery, with negative impacts on short- and long-term clinical outcomes and on healthcare costs. Recently, clinical interest has been aimed at defining and classifying AKI, identifying risk factors and developing diagnostic strategies to identify patients at risk early on. Achieving an early and accurate diagnosis of AKI is a crucial issue, because prevention and timely detection may help to prevent negative clinical outcomes and avoid AKI-associated costs. In this retrospective study, we evaluate the NephroCheck Test as a diagnostic tool for early detection of AKI in a high-risk population of patients undergoing cardiac surgery at the San Bortolo Hospital of Vicenza.

Methods: We assessed the ability of the NephroCheck Test to predict the probability of developing CSA-AKI (cardiac surgery-associated AKI) and evaluated its accuracy as a diagnostic test, by building a multivariate logistic regression model for CSA-AKI prediction.

Results: Based on our findings, when the results of the NephroCheck Test are included in a multivariate model its performance is substantially improved, as compared to the benchmark model, which only accounts for the other clinical factors. We also define a rule - in terms of a probability cut-off - for discriminating cases that are at higher risk of developing AKI of any stage versus those in which AKI is less likely.

Conclusions: Our study has implications in clinical practice: when a Nephrocheck Test result is >0.3 ng/dL, an automated electronic alert prompts the physician to intervene by following a checklist of preventive measures.
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http://dx.doi.org/10.5301/ijao.5000661DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6154726PMC
November 2017

Airway management with Fastrach laryngeal mask versus Spritztube: a prospective randomized manikin-based study.

Minerva Anestesiol 2018 04 4;84(4):455-462. Epub 2017 Oct 4.

Department of Anesthesiology and Intensive Care, San Bortolo Hospital, Vicenza, Italy.

Background: A new promising device, the Spritztube (ST), was developed combining the ability to perform both supraglottic ventilation and orotracheal fibreoptic intubation using the same device, allowing an easy passage from supraglottic ventilation to tracheal ventilation avoiding apnea. The present study aims to compare the speed and the subjective ease of insertion of the novel tracheal tube (Spritztube®) compared to the intubating laryngeal mask airway Fastrach™ (FT-LMA) in a simulation environment.

Methods: Each participant received verbal instruction and practical demonstration concerning "technique of insertion" for both devices on manikin and, in a randomized order, used both devices. Time of placement (T1), time of inflation (T2), the elapsed procedural time (T3), ease of insertion, time of exchange maneuver for intubation (T4), success rates and number of attempts were recorded for each EAD.

Results: Forty-seven participants were enrolled. The ST was judged as easier insertion than FT-LMA (P<0.001) having also a significant higher success rate than FT-LMA (P<0.001). Number of attempts for insertion was similar. Number of attempts for exchange to ETI was significantly more for FT-LMA (P<0.001). FT-LMA was applied 11 s faster than the ST (median T3 Fastrach: 13 s, ST: 24 s, P<0.001) as the exchange maneuver for ETI (median T4 FT-LMA: 13 s, ST: 24 s, P<0.001).

Conclusions: In a manikin simulation setting, insertion and intubation with and ST was performed 11 s slower than with use of a FT-LMA.
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http://dx.doi.org/10.23736/S0375-9393.17.11702-5DOI Listing
April 2018

Prospective, Randomized, Multicenter, Controlled Trial (TRIATHRON 1) on a New Antithrombogenic Hydrophilic Dialysis Membrane.

Int J Artif Organs 2017 May;40(5):234-239

Department of Immunology and Blood Transfusion, San Bortolo Hospital, Vicenza - Italy.

Introduction: Hemodialysis treatment requires anticoagulation to prevent thrombosis of the dialyzer. The Hydrolink (NV series; Toray) has been designed to reduce thrombotic complications by increasing membrane hydrophilic properties. Previous studies have confirmed reduced platelet activation, improved removal of β2-microglobulin and excellent small-solute removal.

Methods: We designed a prospective, multi-centered, randomized clinical study to compare the antithrombogenic effects (platelet count) of NV dialyzers versus conventional treatment. To compare the possibility of performing heparin-free dialysis, we carried out progressive heparin reduction tests. Patients with an average platelet count lower than 170,000 cells/mm using standard high flux membranes in the 6 months prior to the study were enrolled and randomized. Patients were either dialyzed for 6 months without changing the previous membrane (control group) or treated with the Hydrolink membrane (NV group). After the third week, the heparin reduction test was conducted for 5 weeks in order to assess the minimum amount of anticoagulant needed to safely perform a 4-hour dialysis treatment. Performance and safety were evaluated measuring platelet count and activation, middle-molecule removal rate and nutritional status.

Results: We found no significant difference in platelet count, platelet activation factors β-thromboglobulin and platelet factor 4 (PF-4), between the groups. More patients in the study group reached heparin-free dialysis without clotting events during the heparin reduction test. The NV dialyzers displayed anti-thrombogenic effects as compared to conventional dialyzers.

Conclusions: The NV dialyzer series is safe with no adverse events reported. Further studies are required to understand the mechanisms of anti-thrombogenic effects.
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http://dx.doi.org/10.5301/ijao.5000608DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6159854PMC
May 2017

Development of the New Kibou® Equipment for Continuous Renal Replacement Therapy from Scratch to the Final Configuration.

Contrib Nephrol 2017 23;190:58-70. Epub 2017 May 23.

A new technology has recently appeared in the area of extracorporeal therapies for critically ill patients with acute kidney injury. The International Renal Research Institute of Vicenza was involved from the beginning in the development of a new continuous renal replacement therapy (CRRT) equipment with peculiar characteristics. We report the overall experience from design of the new machine to its in vitro and in vivo testing. Kibou® (Asahi Kasei Kuraray Medical Co., Ltd., Tokyo, Japan) is a new multifunctional machine designed for delivering RRT. Kibou® carries out many features of the fourth generation CRRT machines including the possibility of a dynamic prescription and reduction of nursing workload. We describe our first experience with this new device, focusing on several usability and performance parameters. A specific in vitro protocol was designed to analyze the various characteristics and accuracy of performance of the machine. Furthermore, a preliminary in vivo alpha trial with 12 CRRT sessions was performed to test, characterize and evaluate the machine in terms of usability, flexibility and reliability. The in vitro evaluation confirmed an adequate design and a good usability of the machine with accurate delivery of prescribed parameters. No adverse events were observed during the in vivo test that confirmed usability and safety together with accuracy of treatment delivery in different modalities. In general, the machine was rated by physicians and nurses involved in the evaluation as practical and easy to use, although a specific training is required to familiarize with the equipment. A large-scale multicenter beta trial is required to confirm the results reported in this preliminary evaluation in terms of safety, accuracy and performance of Kibou®.
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http://dx.doi.org/10.1159/000468914DOI Listing
March 2018
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