Abstract
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 RegistrationClinicaltrials.gov NCT01761994
Highlights
Continuous renal replacement therapy (CRRT) is an effective renal replacement modality used to manage hemodynamically unstable patients with deteriorated renal function [1]
Patients and study design In this unblinded, single center, randomized, prospective controlled study, 73 patients (18–80 years old) who were admitted to the intensive care unit (ICU) for CRRT with hemorrhagic tendency were enrolled from September 2007 to August 2010 at Severance Hospital, Seoul, Republic of Korea
At the start of CRRT, no significant differences between groups according to age, sex, vital signs, laboratory tests, or acute kidney injury when stratified by RIFLE criteria, APACHE II score, and the Cleveland Clinical Foundation Score were found (Table 1)
Summary
Continuous renal replacement therapy (CRRT) is an effective renal replacement modality used to manage hemodynamically unstable patients with deteriorated renal function [1]. There are risks associated with the use of heparin as an anticoagulant in patients at high risk of bleeding. The extremely short half-life makes it a suitable substitute for heparin in patients with a high tendency for bleeding [8,9,10]. Even though a few retrospective studies have shown that nafamostat mesilate is effective in CRRT among patients at high risk of bleeding [11,12,13], no prospective study has evaluated the effect of nafamostat mesilate under controlled conditions. To elucidate the efficacy and safety of nafamostat mesilate, we performed a single center, randomized, controlled study in CRRT patients with high risk of bleeding
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