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

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478242
• Other study ID #: KNUH_08-0023
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2015
• Last updated: June 22, 2015
• Start date: July 2010
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• Nafamostat mesilate
nafamostat mesilate use for anticoagulation
• Normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of filters used per hour		24 months	Yes
Secondary	Urea reduction ratio		24 months	Yes
Secondary	Survival rate		24 months	Yes