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

Study Overview
=================
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.

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: Anticoagulation with nafamostat mesilate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have at least one of the hemorrhagic tendencies of following conditions and needs CRRT hemodynamically; Platelet count < 100,000 aPTT > 60 sec PT-INR > 2.0 active hemorrhage surgery within 48 hours cerebral hemorrhage within 3 months or history of major bleeding septic shock or DIC. Exclusion Criteria: pregnancy, breast feeding, possibility of pregnancy, allergy to nafamostat mesilate, other conditions that physician consider unfit for candidate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: M100<br>heparin free CRRT group | Drug: Anticoagulation with nafamostat mesilate<br>* 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.<br>* Other names: futhan;|
| Experimental: HF1000<br>CRRT with nafamostat mesilate anticoagulation group | Drug: Anticoagulation with nafamostat mesilate<br>* 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.<br>* Other names: futhan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | Mortality in intensive care unit | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heparin, nafamostat mesilate, continuous renal replacement therapy