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Clinical Trials in China / NCT07469072
Recruiting Phase 2

Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU)

NCT07469072 · tracked via the Priya Life Science China tracker
Sponsor
Zhujiang Hospital
Phase
Phase 2
Started
2026-04-07
Last updated
2026-04-14

Condition(s) studied

Continuous Renal Replacement Therapy (CRRT)

Investigational drug(s) / intervention(s)

Nafamostat Low-Dose GroupNafamostat High-Dose Group

Nafamostat Low-Dose Group: 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 High-Dose Group: 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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age \& Gender: Aged 18 to 80 years, regardless of gender. 2. 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. 3. 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 4. Platelet Count: Platelet count (PLT) ≥ 50 × 10⁹/L. 5. Body Mass Index (BMI): 18.5 kg/m² ≤ BMI ≤ 25 kg/m². 6. Informed Consent: Written informed consent obtained from the patient or their legally authorized representative. Exclusion Criteria: 1. Hypersensitivity: Known allergy or hypersensitivity to Nafamostat Mesilate or any component of the formulation. 2. 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). 3. Pregnancy/Lactation: Pregnant or breastfeeding women. 4. 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. 5. 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). 6. Severe Liver Dysfunction: Severe hepatic impairment (Child-Pugh Class C) or baseline total bilirubin levels exceeding 5 times the upper limit of normal. 7. Limited Life Expectancy: Expected survival time of less than 24 hours due to the progression of underlying disease. 8. Conflicting Trials: Current participation in another interventional clinical trial that may influence the outcomes of this study.

Primary outcome measure(s)

  • Filter Lifespan — From the initiation of Nafamostat Mesilate anticoagulation until filterreplacement or discontinuation of CRRT (up to 72 hours per filter session).
    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.

Trial sites (1)

FacilityCityRegionStatus
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07469072 on ClinicalTrials.gov ↗ ← All trials in China