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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Anticoagulation with nafamostat mesilate
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring nafamostat mesilate, heparin, continuous renal replacement therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

M100

HF1000

Arm Description

heparin free CRRT group

CRRT with nafamostat mesilate anticoagulation group

Outcomes

Primary Outcome Measures

mortality
Mortality in intensive care unit

Secondary Outcome Measures

Full Information

First Posted
December 24, 2012
Last Updated
January 3, 2013
Sponsor
Yonsei University
Collaborators
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01761994
Brief Title
The Effect of Nafamostat Mesilate in Prolonging Filter Patency With Patients on Continuous Renal Replacement Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
Collaborators
SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
nafamostat mesilate, heparin, continuous renal replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M100
Arm Type
Active Comparator
Arm Description
heparin free CRRT group
Arm Title
HF1000
Arm Type
Experimental
Arm Description
CRRT with nafamostat mesilate anticoagulation group
Intervention Type
Drug
Intervention Name(s)
Anticoagulation with nafamostat mesilate
Other Intervention Name(s)
futhan
Intervention Description
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.
Primary Outcome Measure Information:
Title
mortality
Description
Mortality in intensive care unit
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33314078
Citation
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.
Results Reference
derived
PubMed Identifier
25302581
Citation
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.
Results Reference
derived

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

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