Actively Recruiting
Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU)
Led by Zhujiang Hospital · Updated on 2026-04-14
92
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, randomized, open-label, parallel-controlled clinical trial designed to investigate the anticoagulation efficacy and safety of different initial doses of Nafamostat Mesilate (NM) in ICU patients undergoing Continuous Renal Replacement Therapy (CRRT). Researchers will screen patients admitted to the Department of Critical Care Medicine at Zhujiang Hospital, Southern Medical University, to identify eligible participants based on inclusion and exclusion criteria. After obtaining informed consent, participants will be randomized into two groups. On the basis of standardized CRRT treatment, the Low-Dose Group (Group A) will receive a continuous infusion of Nafamostat Mesilate at an initial dose of 20 mg/h, while the High-Dose Group (Group B) will receive an initial dose of 50 mg/h. The drug will be continuously infused pre-filter into the CRRT circuit. Dosage adjustments will be made for both groups to maintain target anticoagulation levels while ensuring that pre-filter safety limits are not exceeded. The primary outcome measure is filter lifespan, along with other secondary outcomes.
CONDITIONS
Official Title
Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years, any gender
- Admitted to ICU and requiring Continuous Renal Replacement Therapy (CRRT) for more than 24 hours
- Normal coagulation function before CRRT: INR less than or equal to 1.5, Fibrinogen at least 1.5 g/L, APTT less than or equal to 45 seconds
- Platelet count at least 50 x 10⁹/L
- Body Mass Index (BMI) between 18.5 and 25 kg/m²
- Provided written informed consent personally or via authorized representative
You will not qualify if you...
- Known allergy or hypersensitivity to Nafamostat Mesilate or its components
- Active bleeding or high bleeding risk that makes anticoagulation unsafe
- Pregnant or breastfeeding women
- Current use of other systemic anticoagulants that cannot be stopped
- Using other extracorporeal life support devices like ECMO, Intra-Aortic Balloon Pump, or Plasma Exchange
- Severe liver disease (Child-Pugh Class C) or very high bilirubin levels
- Expected to live less than 24 hours due to their illness
- Participating in another clinical trial that might affect this study's results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, China, 510282
Actively Recruiting
Research Team
Z
Zhanguo Liu, M.D.PhD
CONTACT
Z
Zhanguo Liu, M.D.PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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