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

Phase 4

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Anticoagulation with nafamostat mesilate

• Registration Number: NCT01761994
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2012-12-24
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Study First Posted: 2013-01-07
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

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Exclusion Criteria

• pregnancy, breast feeding, possibility of pregnancy,
• allergy to nafamostat mesilate,
• other conditions that physician consider unfit for candidate.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M100	Anticoagulation with nafamostat mesilate	heparin free CRRT group
HF1000	Anticoagulation with nafamostat mesilate	CRRT with nafamostat mesilate anticoagulation group

Primary Outcome Measures

Name	Time	Method
mortality	2 years	Mortality in intensive care unit

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of