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Multicenter Prospective Cohort Study of Renal Failure in Patients Treated with Colistin versus Polymyxin B.

ABSTRACT: Nephrotoxicity is the main adverse effect of colistin and polymyxin B (PMB). It is not clear whether these two antibiotics are associated with different nephrotoxicity rates. We compared the incidences of renal failure (RF) in patients treated with colistimethate sodium (CMS) or PMB for ?48 h. A multicenter prospective cohort study was performed that included patients aged ?18 years. The primary outcome was renal failure (RF) according to Risk, Injury, Failure, Loss, and End-stage renal disease (RIFLE) criteria. Multivariate analysis with a Cox regression model was performed. A total of 491 patients were included: 81 in the CMS group and 410 in the PMB group. The mean daily doses in milligrams per kilogram of body weight were 4.2 ± 1.3 and 2.4 ± 0.73 of colistin base activity and PMB, respectively. The overall incidence of RF was 16.9% (83 patients): 38.3% and 12.7% in the CMS and PMB groups, respectively (P< 0.001). In multivariate analysis, CMS therapy was an independent risk factor for RF (hazard ratio, 3.35; 95% confidence interval, 2.05 to 5.48;P< 0.001) along with intensive care unit admission, higher weight, older age, and bloodstream and intraabdominal infections. CMS was also independently associated with a higher risk of RF in various subgroup analyses. The incidence of RF was higher in the CMS group regardless of the patient baseline creatinine clearance. The development of RF during therapy was not associated with 30-day mortality in multivariate analysis. CMS was associated with significantly higher rates of RF than those of PMB. Further studies are required to confirm our findings in other patient populations.

SUBMITTER: Rigatto MH

PROVIDER: S-EPMC4808237 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Multicenter Prospective Cohort Study of Renal Failure in Patients Treated with Colistin versus Polymyxin B.

Rigatto Maria Helena MH Oliveira Maura S MS Perdigão-Neto Lauro V LV Levin Anna S AS Carrilho Claudia M CM Tanita Marcos Toshiyuki MT Tuon Felipe F FF Cardoso Douglas E DE Lopes Natane T NT Falci Diego R DR Zavascki Alexandre P AP

Antimicrobial agents and chemotherapy 20160325 4

Nephrotoxicity is the main adverse effect of colistin and polymyxin B (PMB). It is not clear whether these two antibiotics are associated with different nephrotoxicity rates. We compared the incidences of renal failure (RF) in patients treated with colistimethate sodium (CMS) or PMB for ≥48 h. A multicenter prospective cohort study was performed that included patients aged ≥18 years. The primary outcome was renal failure (RF) according to Risk, Injury, Failure, Loss, and End-stage renal disease ...[more]

PMID: 26856846

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Project description:BackgroundIn patients with heart failure (HF), physical frailty should be assessed to enable risk stratification. No conventional frailty criteria have so far been developed considering HF-specific outcomes. This study aimed to propose a frailty-based prognostic score using a nationwide cohort study of Japanese patients with HF.MethodsWe analysed 2721 patients hospitalized for HF and capable of walking at discharge (median age: 76 years [interquartile range 67-83], men: 60.5%). Physical frailty was evaluated at discharge using four quantitative measures: usual walking speed, grip strength, Performance Measure for Activities of Daily Living-8 (PMADL-8), and Self-Efficacy for Walking-7 (SEW-7). The primary outcome was a composite of HF rehospitalization and all-cause mortality within 2 years. A cut-off point was identified for each measure using receiver operating characteristic analysis in a derivation cohort (n = 1778). Cox proportional hazards model was used to assign a score to each frailty domain according to the correlation with the endpoint. Patients were divided into four categories according to the sum score, and survival was compared by analysing the Kaplan-Meier curve and Cox proportional hazards model. Cumulative incidences of the events according to frailty categories were compared between the derivation cohort and a validation cohort (n = 943).ResultsThe cut-off value and assigned score of each indicator was determined as follows: usual walking speed < 0.98 m/s = 4 points; grip strength < 30.0 kg (men) or 17.5 kg (women) = 5 points; PMADL-8 ≥ 21 points = 2 points; SEW-7 ≤ 20 points = 3 points. We stratified patients into four categories according to the sum score: Category I, ≤3 points; Categories II, 4-8 points; Category III, 9-13 points; and Category IV, 14 points. The prevalence and cumulative incidence of the composite outcome for Categories I to IV in the derivation cohort were 27.4%, 25.2%, 26.4%, and 21.0%, and 9.5, 16.3, 26.3, and 36.8/100 person-years, respectively. Similar results were confirmed in the validation cohort. In Cox proportional hazards model, frailty categories were associated with the composite outcome independent of potential confounders (hazard ratio [95% confidence interval] in reference to Category I: Categories II, 1.51 [0.84-2.72], P = 0.169; Category III, 2.37 [1.32-4.23], P = 0.004; Category IV, 2.66 [1.45-4.89], P = 0.002).ConclusionsThe frailty-based prognostic score proposed in this study was well associated with prognosis and will serve for risk stratification in patients with HF.

Project description:BackgroundStatins are widely used for treating patients with ischemic stroke at risk of secondary cerebrovascular events. It is unknown whether Asian populations benefit from more intensive statin-based therapy for stroke recurrence. Therefore, in the present study we evaluated the effectiveness and safety of high-dose and moderate-dose statins for patients who had experienced mild ischemic stroke during the acute period.Methods and resultsThis multicenter prospective study included patients with mild ischemic stroke who presented within 72 hours of symptom onset. The outcomes of patients in the high-intensity and moderate-intensity statin treatment groups were compared, with the main efficacy outcome being stroke recurrence and the primary safety end point being intracranial hemorrhage. The propensity score matching method was employed to control for imbalances in baseline variables. Subgroup analyses were conducted to evaluate group differences. In total, the data of 2950 patients were analyzed at 3 months, and the data of 2764 patients were analyzed at 12 months due to loss to follow-up. According to the multivariable Cox analyses adjusted for potential confounders, stroke recurrence occurred similarly in the high-intensity statin and moderate-intensity statin groups (3 months: adjusted hazard ratio [HR], 1.12 [95% CI, 0.85-1.49]; P=0.424; 12 months: adjusted HR, 1.08 [95% CI, 0.86-1.34]; P=0.519). High-intensity statin therapy was associated with an increased risk of intracranial hemorrhage (3 months: adjusted HR, 1.81 [95% CI, 1.00-3.25]; P=0.048; 12 months: adjusted HR, 1.86 [95% CI, 1.10-3.16]; P=0.021). The results from the propensity score-matched analyses were consistent with those from the Cox proportional hazards analysis.ConclusionsCompared with moderate-intensity statin therapy, high-dose statin therapy may not decrease the risk of mild, noncardiogenic ischemic stroke recurrence but may increase the risk of intracranial hemorrhage.RegistrationURL: www.chictr.org.cn/. Unique Identifier: ChiCTR1900025214.

Project description:Abstract Background Polymyxins are one of the last resort treatments for carbapenem resistant gram-negative infections. Nephrotoxicity is its main adverse effect and has been related to oxidative stress mechanisms. Melatonin was associated to reduction in polymyxins nephrotoxicity in animal studies. Our objective is to evaluate the effect of melatonin on renal protection of patients receiving polymyxin B. Methods We did a single center, double blind, randomized clinical trial (NCT03725267) of melatonin 30mg versus placebo for patients treated with polymyxin B from October 2018 to April 2021, in Porto Alegre, Brazil. Patients ≥18 years old, receiving polymyxin B for ≤48 hours, who accepted informed consent terms were included and excluded if intensive care unit (ICU) admission at enrollment, estimated glomerular rate estimated glomerular rate < 10ml/min, dialysis or previous melatonin use. Treatment with melatonin or placebo was randomized in blocks of 4 and maintained until the end of polymyxin B treatment of for a maximum of 14 days. Our main outcome was any level of nephrotoxicity by RIFLE score. Secondary outcomes were renal failure and need for dialysis. We estimated a sample size of 100 patients, however the study had to be stopped earlier due to recruitment restrictions imposed by the COVID-19 pandemic. Results Eighty-eight patients were randomized, 44 received melatonin and 44 received identical placebo pills. Patients had a mean age of 63.6±17.3 years, 60.2% were male, and had a median Charlson index of 5 (3-8.3). Most infections (79.5%) were microbiologically confirmed, having 68.6% Klebsiella sp isolated. Urinary tract accounted for47.7% of infection sites. Median time of polymyxin B therapy was 9.1±6.6 days. Combination therapy was prescribed for 89.8% of patients and 38.6% received at least another nephrotoxic drug. All variables were equally distributed among groups. Nephrotoxicity rates occurred in 23 of 44 (52.3%) in both groups, P=0.99. Patients who developed renal failure were 8(18.2%) vs 9(20.5%) and dialysis occurred in 4(9.1%) vs 5 (11.4%) of melatonin and placebo groups respectively. Conclusion Melatonin did not show a clinically significant renal protective effect in patients treated with polymyxin B. Disclosures Maria Helena Rigatto, MD, PhD, CNPq (Grant/Research Support) Diego Rodrigues Falci, MD, MSc, PhD, Gilead Sciences (Grant/Research Support, Scientific Research Study Investigator, Speaker’s Bureau)GSK (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member)MSD (Speaker’s Bureau)Pfizer (Speaker’s Bureau)United Medical (Speaker’s Bureau, Other Financial or Material Support) Alexandre Zavascki, MD, PhD, Pfizer (Grant/Research Support)

Dataset Information

Multicenter Prospective Cohort Study of Renal Failure in Patients Treated with Colistin versus Polymyxin B.

Publications

Multicenter Prospective Cohort Study of Renal Failure in Patients Treated with Colistin versus Polymyxin B.

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