Key result
In ICU patients with bleeding tendencies requiring CRRT, nafamostat mesilate did not significantly alter overall mortality compared to no anticoagulation (75.00% vs 74.07%, p=0.927), but it significantly prolonged filter patency.
Why the study?
Does nafamostat mesilate improve CRRT filter life span and reduce mortality in ICU patients at high risk of bleeding compared to no anticoagulation?
RCT (n=73)
Open-label
Randomized with stratification by diabetes mellitus
No
Does nafamostat mesilate improve CRRT filter life span and reduce mortality in ICU patients at high risk of bleeding compared to no anticoagulation?
Absolute Event Rate: 75% vs 74.07%
p-value: p=0.927
Nafamostat mesilate safely prolongs CRRT filter patency without increasing bleeding risk in hemodynamically unstable ICU patients prone to bleeding.
May support nafamostat use in select high-bleed-risk CRRT; leaves open need for randomized confirmation before practice change.
UNLABELLED: 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.
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Lee et al. (2014) conducted an RCT in Hemorrhagic tendency requiring continuous renal replacement therapy (CRRT) (n=73). Nafamostat mesilate vs. No anticoagulation was evaluated on Overall mortality (p=0.927). In ICU patients with bleeding tendencies requiring CRRT, nafamostat mesilate did not significantly alter overall mortality compared to no anticoagulation (75.00% vs 74.07%, p=0.927), but it significantly prolonged filter patency.
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