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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury

Treatments: Drug: Anticoagulation with nafamostat mesilate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01761994

4-2007-0220

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

M100

Active Comparator group

Description:

heparin free CRRT group

Treatment:

Drug: Anticoagulation with nafamostat mesilate

HF1000

Experimental group

Description:

CRRT with nafamostat mesilate anticoagulation group

Treatment:

Drug: Anticoagulation with nafamostat mesilate