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

Phase 4

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Nafamostat mesilate; Drug: Normal saline

• Registration Number: NCT02478242
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2010-07
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Study First Posted: 2015-06-23
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nafamostat mesilate group	Nafamostat mesilate	Nafamostat mesilate was used for maintenance anticoagulation during continuous renal replacement therapy.
No anticoagulation group	Normal saline	Normal saline was used for maintenance anticoagulation during continuous renal replacement therapy.

Primary Outcome Measures

Name	Time	Method
Number of filters used per hour	24 months

Secondary Outcome Measures

Name	Time	Method
Urea reduction ratio	24 months
Survival rate	24 months