Trial to Assess the Efficacy and Safety of Nafamostat Mesilate During Continuous Renal Replacement Therapy

Kyungpook National University Hospital60 enrolled

Overview

Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.

Patients were randomly assigned to the nafamostat mesilate (NM) group or the no anticoagulant (NA) group. In patients assigned to the NM group, NM (20mg/h) was used for maintenance anticoagulation. Whereas, in patients assigned to the NA group, normal saline (2mL/h) was infused for continuous renal replacement therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Kidney Injury

Interventions

Nafamostat mesilateDRUG

nafamostat mesilate use for anticoagulation

Normal salineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who were admitted to the intensive care unit and required CRRT 1. active bleeding such as gastrointestinal bleeding and intracranial hemorrhage, 2. activated partial thromboplastin time \> 60 s, 3. prothrombin time-international normalized ratio \> 2.0, 4. thrombocytopenia (\<100,000/µL), and 5. surgery within 48 h before CRRT. Exclusion Criteria: * Pregnant or possibly pregnant women * Patients who were allergic to nafamostat mesilate * Patients who were hypercoagulable

Outcomes

Primary Outcomes

Number of filters used per hour

Time frame: 24 months

Secondary Outcomes

Urea reduction ratio

Time frame: 24 months

Survival rate

Time frame: 24 months

Data from ClinicalTrials.gov

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