drugset / Trial / NCT07469072

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

NCT07469072

Phase 2 Recruiting 92 enrolled Zhujiang Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-04-07
Primary completion
2027-03-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nafamostat Small molecule 20 mg Intravenous
Subject Nafamostat Small molecule 50 mg Intravenous

Indications

No indication recorded.