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

NCT01761994 | Completed Phase 4

• 1 other identifier: 4-2007-0220
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

nafamostat mesilate; heparin; continuous renal replacement therapy

Outcome Measures

Primary Outcomes (1)

• mortality

  Mortality in intensive care unit

  2 years

Study Arms (2)

M100

ACTIVE COMPARATOR

heparin free CRRT group

Drug: Anticoagulation with nafamostat mesilate

HF1000

EXPERIMENTAL

CRRT with nafamostat mesilate anticoagulation group

Drug: Anticoagulation with nafamostat mesilate

Interventions

Anticoagulation with nafamostat mesilate DRUG

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.

Also known as: futhan

HF1000; M100

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead
• SK Chemicals Co., Ltd.: collaborator

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (2)

• Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.

  PMID: 33314078 DERIVED

• Lee YK, Lee HW, Choi KH, Kim BS. Ability of nafamostat mesilate to prolong filter patency during continuous renal replacement therapy in patients at high risk of bleeding: a randomized controlled study. PLoS One. 2014 Oct 10;9(10):e108737. doi: 10.1371/journal.pone.0108737. eCollection 2014.

  PMID: 25302581 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

nafamostat

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2012
• First Posted: January 7, 2013
• Study Start: September 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

KR (1)