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

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761994
• Other study ID #: 4-2007-0220
• Status: Completed
• Phase: Phase 4
• First received: December 24, 2012
• Last updated: January 3, 2013
• Start date: September 2007
• Est. completion date: August 2010

Study information

• Verified date: January 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	Mortality in intensive care unit	2 years	No