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.
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.
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.
Parallel
Nafamostat Low-Dose Group
DrugNafamostat 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 High-Dose Group
DrugNafamostat 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
Filter Lifespan
Defined as the duration (in hours) from the initiation of Nafamostat Mesilate anticoagulation in the CRRT circuit to the discontinuation of Nafamostat anticoagulation due to any of the following reasons: (i) Filter replacement; (ii) Termination of CRRT due to: filter clotting, prolonged filter downtime, renal recovery, patient transfer out of the ICU, or death; (iii) Discontinuation of Nafamostat anticoagulation due to adverse events such as bleeding, necessitating a change in the anticoagulation strategy. Data Source: Nursing records and medical charts.
Filter Transmembrane Pressure (TMP) Changes
TMP of the CRRT filter will be measured at the following time points after initiation of Nafamostat Mesilate anticoagulation: * Day 1: 2hours, 8hours, 16hours, 24hours * Day 2: 8hours, 16hours, 24hours (equivalent to 32hours, 40hours, 48hours from start) * Day 3: 8hours, 16hours, 24hours (equivalent to 56hours, 64hours, 72hours from start) Data obtained from nursing records and medical charts.
Incidence of Filter Clotting Events
Defined as Transmembrane Pressure (TMP) exceeding 250 mmHg and/or visible clotting in the air collection chamber. Data obtained from nursing records and medical charts.
Duration of CRRT
The total duration of the CRRT treatment session. Data obtained from nursing records and medical charts.
Delivered CRRT Dose
The actual delivered dose of CRRT treatment. Data obtained from nursing records and medical charts.
Click on the lead sponsor to view all of their trials.
