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

This study has been completed.
Sponsor:
Collaborator:
SK Chemicals Co.,Ltd.
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01761994
First received: December 24, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Acute Kidney Injury
 Drug: Anticoagulation with nafamostat mesilate
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Mortality in intensive care unit


Enrollment: 66
Study Start Date: September 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: futhan

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761994

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
SK Chemicals Co.,Ltd.
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01761994     History of Changes
Other Study ID Numbers: 4-2007-0220
Study First Received: December 24, 2012
Last Updated: January 3, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
nafamostat mesilate
heparin
continuous renal replacement therapy

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Nafamostat
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
 Therapeutic Uses
Antirheumatic Agents
Anticoagulants
Hematologic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013