Dataset Information

Ability of nafamostat mesilate to prolong filter patency during continuous renal replacement therapy in patients at high risk of bleeding: a randomized controlled study.

ABSTRACT:

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Continuous renal replacement therapy (CRRT) is considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care units (ICUs). However, the role of heparin anticoagulation, which is used to maintain circuit patency, is equivocal due to the risk of bleeding and morbidity. Among various alternative anticoagulants, nafamostat mesilate has been shown to be an effective anticoagulant in patients prone to bleeding. Hence, we conducted a prospective, randomized controlled study investigating the effect of nafamostat mesilate on mortality, CRRT filter life span and adverse events in patients with bleeding tendency. Seventy-three Patients were randomized into either the futhan or no-anticoagulation group. Thirty-six subjects in the futhan group received nafamostat mesilate, while thirty seven subjects in the no-anticoagulation group received no anticoagulants. Baseline characteristics and appropriate laboratory tests were taken from each group. The mortality between the two groups was not significantly different. Nevertheless, between the futhan group and the no-anticoagulation group, the overall number of filters used during CRRT (2.71 ± 2.12 vs. 4.50 ± 3.25; p = 0.042) and the number of filters changed due to clots per 24 hours (1.15 ± 0.81 vs. 1.74 ± 1.62; p = 0.040) were significantly different. When filter life span was subdivided into below and over 12 hours, the number of filters functioning over 12 hours was significantly higher in the futhan group than in the no-anticoagulation group (p = 0.037, odds ratio 1.84). There were no significant differences in transfusion, mortality, or survival between the two groups, and no adverse events related to nafamostat mesilate were noted. Hence, nafamostat mesilate may be used as an effective and safe anticoagulant, without increasing the risk of major bleeding complications, in patients prone to bleeding.

Trial registration

Clinicaltrials.gov NCT01761994.

SUBMITTER: Lee YK

PROVIDER: S-EPMC4193755 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Ability of nafamostat mesilate to prolong filter patency during continuous renal replacement therapy in patients at high risk of bleeding: a randomized controlled study.

Lee Yong Kyu YK Lee Hae Won HW Choi Kyu Hun KH Kim Beom Seok BS

PloS one 20141010 10

<h4>Unlabelled</h4>Continuous renal replacement therapy (CRRT) is considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care units (ICUs). However, the role of heparin anticoagulation, which is used to maintain circuit patency, is equivocal due to the risk of bleeding and morbidity. Among various alternative anticoagulants, nafamostat mesilate has been shown to be an effective anticoagulant in patients prone to bleeding. Hence, we ...[more]

PMID: 25302581

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Project description:INTRODUCTION: Despite studies demonstrating benefit, patients with femoral vascular catheters placed for continuous renal replacement therapy are frequently restricted from mobilization. No researchers have reported filter pressures during mobilization, and it is unknown whether mobilization is safe or affects filter lifespan. Our objective in this study was to test the safety and feasibility of mobilization in this population. METHODS: A total of 33 patients undergoing continuous renal replacement therapy via femoral, subclavian or internal jugular vascular access catheters at two general medical-surgical intensive care units in Australia were enrolled. Patients underwent one of three levels of mobilization intervention as appropriate: (1) passive bed exercises, (2) sitting on the bed edge or (3) standing and/or marching. Catheter dislodgement, haematoma and bleeding during and following interventions were evaluated. Filter pressure parameters and lifespan (hours), nursing workload and concern were also measured. RESULTS: No episodes of filter occlusion or failure occurred during any of the interventions. No adverse events were detected. The intervention filters lasted longer than the nonintervention filters (regression coefficient?=?13.8 (robust 95% confidence interval (CI)?=?5.0 to 22.6), P?=?0.003). In sensitivity analyses, we found that filter life was longer in patients who had more position changes (regression coefficient?=?2.0 (robust 95% CI?=?0.6 to 3.5), P?=?0.007). The nursing workloads between the intervention shift and the following shift were similar. CONCLUSIONS: Mobilization during renal replacement therapy via a vascular catheter in patients who are critically ill is safe and may increase filter life. These findings have significant implications for the current mobility restrictions imposed on patients with femoral vascular catheters for renal replacement therapy. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12611000733976 (registered 13 July 2011).

Project description:BackgroundCurrent guidelines recommend monitoring of post-filter ionized calcium (pfCa) when using regional citrate anticoagulation during continuous renal replacement therapy (RCA-CRRT) to determine citrate efficiency for the prevention of filter clotting. However, the reliability of pfCa raises the question of whether routine monitoring is required. Reducing the frequency of pfCa monitoring could potentially reduce costs and workload. Our objective was to test the efficacy and safety of no pfCa monitoring among critically ill patients receiving RCA-CRRT.MethodsThis study was a non-inferiority randomized controlled trial conducted between January 2021 and October 2021 at King Chulalongkorn Memorial Hospital, Thailand. Critically ill patients who were treated with RCA-CRRT were randomized to receive either standard pfCa monitoring (aiming pfCa level of 0.25-0.35 mmol/L), or no pfCa monitoring, in which a constant rate of citrate infusion was maintained at pre-determined citrate concentrations of 4 mmol/L with blinding of pfCa levels to treating clinicians. The primary outcome was the filter lifespan. Non-inferiority would be demonstrated if the upper limit of the 95% confidence interval (CI) for the difference in filter lifespan between the groups was less than 20 h.ResultsFifty patients were randomized to the standard pfCa monitoring group (n = 25) or no pfCa monitoring group (n = 25). The mean filter lifespan was 54 ± 20 h in the standard pfCa monitoring group and 47 ± 23 h in the no pfCa monitoring group (absolute difference 7.1 h; 95% CI -5.3, 19.5, P = .25). When restricting the analysis to circuits reaching the maximum duration of circuit lifespan at 72 h and clotted filters, the filter lifespan was 61 ± 17 h in the standard pfCa group vs 60 ± 19 h in the no pfCa monitoring group (absolute difference 0.9 h; 95% CI -11.5, 13.4, P = .88). Compared with the no pfCa monitoring group, the standard pfCa monitoring group had a significantly higher mean citrate concentrations (4.43 ± 0.32 vs 4 mmol/L, P < .001) and a higher rate of severe hypocalcemia (44% vs 20%, P = .13). No statistical differences were found in filter clotting, citrate accumulation, citrate overload and mortality between the two groups.ConclusionsAmong critically ill patients receiving RCA-CRRT, no pfCa monitoring by maintaining the citrate concentrations of 4 mmol/L is feasible. Larger randomized controlled trials should be conducted to ensure the efficacy, safety and cost-effectiveness of this strategy.Trial registrationClinicalTrials.gov: NCT04792424 (registered 11 March 2021).

Dataset Information

Ability of nafamostat mesilate to prolong filter patency during continuous renal replacement therapy in patients at high risk of bleeding: a randomized controlled study.

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Trial registration

Publications

Ability of nafamostat mesilate to prolong filter patency during continuous renal replacement therapy in patients at high risk of bleeding: a randomized controlled study.

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