Status:
UNKNOWN
Nafamostat Efficacy and Safety in Critically Ill Patients(NICE)
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
SK Chemicals Co., Ltd.
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
20-85 years
Phase:
PHASE3
Brief Summary
Acute kidney injury (AKI) is a common and serious problem in critically ill patients, and is known to be an independent risk factor for mortality. Renal replacement therapy (RRT) is the mainstay of su...
Eligibility Criteria
Inclusion
- Injury stage of RIFLE criteria or more: \> 2-fold increase in the serum creatinine or urine output \< 0.5 mL/kg/hr for 12 hours
- Patients with any dialysis treatment before admission to the ICU or patients with end-stage renal failure and receiving dialysis
- Informed consent has been obtained.
Exclusion
- patient age \< 20 years or \> 85 years
- life expectancy less than 3 months (ex. terminal stage of malignancy)
- Child-Pugh class C liver cirrhosis
- pregnancy or lactation
- history of anticoagulation prior to the randomization
- bleeding tendency (platelet count \< 50,000/ul, INR \> 2.5, PTT \> 65, or fibrinogen \< 1.00 g/L)
- history of hemorrhagic disease (ex. GI bleeding, cerebral hemorrhage, pulmonary hemorrhage)
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01486485
Start Date
March 1 2012
End Date
August 1 2013
Last Update
February 20 2013
Active Locations (4)
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1
National Health Insurance Corporation Ilsan Hospital
Koyang, South Korea
2
Seoul National University Bundang Hospital
Seongnam, South Korea
3
Seoul National University Boramae Medical Center
Seoul, South Korea
4
Seoul National University Hospital
Seoul, South Korea