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

June 22, 2015 updated by: Chan-Duck Kim, M.D., Ph.D., Kyungpook National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Nafamostat mesilate group
Nafamostat mesilate was used for maintenance anticoagulation during continuous renal replacement therapy.
Drug: Nafamostat mesilate
nafamostat mesilate use for anticoagulation
Other Names:
  • Futhan
PLACEBO_COMPARATOR: No anticoagulation group
Normal saline was used for maintenance anticoagulation during continuous renal replacement therapy.
Drug: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of filters used per hour
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Urea reduction ratio
Time Frame: 24 months
24 months
Survival rate
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Investigators

  • Principal Investigator: Chan-Duck Kim, M.D., PhD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (ESTIMATE)

June 23, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUH_08-0023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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