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Completed

NCT Number: NCT01761994

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: futhan

Primary outcomes

  1. mortality

    Time frame: 2 years

    Mortality in intensive care unit

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • SK Chemicals Co., Ltd.

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 7, 2013
Registry last updated
Jan 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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