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Clinical Trials/NCT02478242
NCT02478242CompletedPhase 4

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

Kyungpook National University Hospital0 sites60 target enrollmentStarted: July 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
60
Primary Endpoint
Number of filters used per hour
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who were admitted to the intensive care unit and required CRRT
  • •active bleeding such as gastrointestinal bleeding and intracranial hemorrhage,
  • •activated partial thromboplastin time > 60 s,
  • •prothrombin time-international normalized ratio > 2.0,
  • •thrombocytopenia (<100,000/µL), and
  • •surgery within 48 h before CRRT.

Exclusion Criteria

  • •Pregnant or possibly pregnant women
  • •Patients who were allergic to nafamostat mesilate
  • •Patients who were hypercoagulable

Arms & Interventions

Nafamostat mesilate group

Active Comparator

Nafamostat mesilate was used for maintenance anticoagulation during continuous renal replacement therapy.

Intervention: Nafamostat mesilate (Drug)

No anticoagulation group

Placebo Comparator

Normal saline was used for maintenance anticoagulation during continuous renal replacement therapy.

Intervention: Normal saline (Drug)

Outcomes

Primary Outcomes

Number of filters used per hour

Time Frame: 24 months

Secondary Outcomes

  • Urea reduction ratio(24 months)
  • Survival rate(24 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chan-Duck Kim, M.D., Ph.D.

Associate Professor

Kyungpook National University Hospital

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