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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01761994

Enrollment

Registered

2013-01-07

Start date

2007-09-30

Completion date

2010-08-31

Last updated

2013-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

nafamostat mesilate, heparin, continuous renal replacement therapy

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.

Interventions

DRUGAnticoagulation 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
mortality	2 years	Mortality in intensive care unit

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026