Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU)
Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU): A Single-Center, Randomized, Open-Label, Parallel-Controlled Clinical Trial
Zhujiang Hospital
92 participants
Apr 7, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Age \& Gender: Aged 18 to 80 years, regardless of gender.
- Clinical Indication: Admitted to the Intensive Care Unit (ICU) with a confirmed indication for Continuous Renal Replacement Therapy (CRRT) and an expected treatment duration of greater than 24 hours.
- Coagulation Status: Normal coagulation function prior to CRRT initiation, defined as:International Normalized Ratio (INR) ≤ 1.5,Fibrinogen (FIB) ≥ 1.5 g/L,Activated Partial Thromboplastin Time (APTT) ≤ 45 seconds
- Platelet Count: Platelet count (PLT) ≥ 50 × 10⁹/L.
- Body Mass Index (BMI): 18.5 kg/m² ≤ BMI ≤ 25 kg/m².
- Informed Consent: Written informed consent obtained from the patient or their legally authorized representative.
Exclusion Criteria8
- Hypersensitivity: Known allergy or hypersensitivity to Nafamostat Mesilate or any component of the formulation.
- Active Bleeding: Presence of active bleeding or a high risk of bleeding that contraindicates anticoagulation (e.g., active gastrointestinal bleeding, intracranial hemorrhage, or recent major surgery with a high bleeding risk).
- Pregnancy/Lactation: Pregnant or breastfeeding women.
- Concurrent Anticoagulation: Current use of other systemic anticoagulants (e.g., unfractionated heparin, low molecular weight heparin, warfarin, or direct oral anticoagulants) that cannot be discontinued.
- Concurrent Extracorporeal Support: Concurrent use of other extracorporeal life support or blood purification therapies that may interfere with coagulation assessment, such as Extracorporeal Membrane Oxygenation (ECMO), Intra-Aortic Balloon Pump (IABP), or Plasma Exchange (PE).
- Severe Liver Dysfunction: Severe hepatic impairment (Child-Pugh Class C) or baseline total bilirubin levels exceeding 5 times the upper limit of normal.
- Limited Life Expectancy: Expected survival time of less than 24 hours due to the progression of underlying disease.
- Conflicting Trials: Current participation in another interventional clinical trial that may influence the outcomes of this study.
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Interventions
Nafamostat Mesilate will be reconstituted using 5% Glucose Injection. For complete dissolution, at least 1 mL of solvent is added to the 10 mg vial, or at least 5 mL is added to the 50 mg vial. The resulting solution will be administered via continuous infusion into the CRRT circuit pre-filter (infused through a three-way stopcock connected to the blood inlet line of the dialysis circuit) at a maintained rate of 20 mg/h
Nafamostat Mesilate will be reconstituted using 5% Glucose Injection. For complete dissolution, at least 1 mL of solvent is added to the 10 mg vial, or at least 5 mL is added to the 50 mg vial. The resulting solution will be administered via continuous infusion into the CRRT circuit pre-filter (infused through a three-way stopcock connected to the blood inlet line of the dialysis circuit) at a maintained rate of 50 mg/h
Locations(1)
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NCT07469072