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The Effect of Nafamostat Mesilate in Prolonging Filter Patency With Patients on Continuous Renal Replacement Therapy

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01761994
Collaborator
SK Chemicals Co., Ltd. (Industry)
66
Enrollment
1
Location
2
Arms
35
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Continuous renal replacement therapy (CRRT) has been considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care unit (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU patients often make it equivocal to use anticoagulation. This is a prospective randomized controlled study to show the difference in filter life span and adverse event between HF1000 (nafamostat mesilate) group and M100 (heparin-free) group.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anticoagulation with nafamostat mesilate
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: M100

heparin free CRRT group

Drug: Anticoagulation with nafamostat mesilate
Initial dose of nafamostat mesilate is 20mg/hr. Dosage is adjusted from 10mg to 30mg/hr according to patients' status. For priming, two vial of nafamostat mesilate was dissolved in 2mL of 5% glucose fluid, and then mixed with 1000mL of normal saline. After carefully removing air bubble from the circuit with the prepared fluid, nafamostat mesilate was dissolved with 15 mL of 5% glucose fluid and loaded in anticoagulation line with starting dose of 20mg/hr.
Other Names:
  • futhan

    		•
    Experimental: HF1000

    CRRT with nafamostat mesilate anticoagulation group

    Drug: Anticoagulation with nafamostat mesilate
    Initial dose of nafamostat mesilate is 20mg/hr. Dosage is adjusted from 10mg to 30mg/hr according to patients' status. For priming, two vial of nafamostat mesilate was dissolved in 2mL of 5% glucose fluid, and then mixed with 1000mL of normal saline. After carefully removing air bubble from the circuit with the prepared fluid, nafamostat mesilate was dissolved with 15 mL of 5% glucose fluid and loaded in anticoagulation line with starting dose of 20mg/hr.
    Other Names:
  • futhan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. mortality [2 years]

      Mortality in intensive care unit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients who have at least one of the hemorrhagic tendencies of following conditions and needs CRRT hemodynamically;

    1. Platelet count < 100,000

    2. aPTT > 60 sec

    3. PT-INR > 2.0

    4. active hemorrhage

    5. surgery within 48 hours

    6. cerebral hemorrhage within 3 months or history of major bleeding

    7. septic shock or DIC.

    Exclusion Criteria:

    • pregnancy, breast feeding, possibility of pregnancy,

    • allergy to nafamostat mesilate,

    • other conditions that physician consider unfit for candidate.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University
    • SK Chemicals Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT01761994
    Other Study ID Numbers:
    • 4-2007-0220
    First Posted:
    Jan 7, 2013
    Last Update Posted:
    Jan 7, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Yonsei University
    nafamostat mesilate
    heparin
    continuous renal replacement therapy
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Nafamostat

    Study Results

    No Results Posted as of Jan 7, 2013