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

NCT07469072 | Recruiting Phase 2

• 1 other identifier: 2025-KY-539-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Continuous Renal Replacement Therapy (CRRT)

Keywords

Continuous Renal Replacement Therapy (CRRT); Anticoagulation Efficacy; Nafamostat Mesilate (NM)

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (13)

• Filter Transmembrane Pressure (TMP) Changes

  From hour 0 (initiation of anticoagulation) to hour 72 (end of Day 3), with assessments at predefined hourly intervals.

• Incidence of Filter Clotting Events

  From baseline (initiation of CRRT) up to 72 hours post-baseline, or until filter replacement/discontinuation, whichever occurs first.

• Duration of CRRT

  From baseline (initiation of CRRT) up to 72 hours post-baseline, or until filter replacement/discontinuation, whichever occurs first.

• Delivered CRRT Dose

  From initiation of CRRT until filter replacement or discontinuation, up to a maximum of 72 hours per session.

• Activated Partial Thromboplastin Time (APTT)

  At baseline (before CRRT), 2 hours post-baseline, 8 hours post-baseline, and at the last available measurement during treatment (up to 72 hours post-baseline).

Study Arms (2)

Low-Dose Group

EXPERIMENTAL

The patients are administered with continuous renal replacement therapy (CRRT) and standard critical care on the basis of routine treatment. If the patient has not received systemic anticoagulation before enrollment, the patient would be administered with a continuous intravenous infusion of Nafamostat Mesilate at an initial dose of 20 mg/h into the pre-filter port of the CRRT circuit. Meanwhile, the dose of Nafamostat should be titrated according to post-filter Activated Clotting Time (ACT) or Activated Partial Thromboplastin Time (APTT) to maintain the target anticoagulation level (post-filter ACT 150-250 s or APTT 50-70 s). Alternative anticoagulants or no anticoagulation could be administered to the patients if bleeding complications occur or if the target anticoagulation levels cannot be achieved safely, and the medication changes and dosage adjustments are recorded.

Drug: Nafamostat Low-Dose Group

High-Dose Group

EXPERIMENTAL

The patients are administered with continuous renal replacement therapy (CRRT) and standard critical care on the basis of routine treatment. If the patient has not received systemic anticoagulation before enrollment, the patient would be administered with a continuous intravenous infusion of Nafamostat Mesilate at an initial dose of 50 mg/h into the pre-filter port of the CRRT circuit. Meanwhile, the dose of Nafamostat should be titrated according to post-filter Activated Clotting Time (ACT) or Activated Partial Thromboplastin Time (APTT) to maintain the target anticoagulation level (post-filter ACT 150-250 s or APTT 50-70 s). Alternative anticoagulants or no anticoagulation could be administered to the patients if bleeding complications occur or if the target anticoagulation levels cannot be achieved safely, and the medication changes and dosage adjustments are recorded.

Drug: Nafamostat High-Dose Group

Interventions

Nafamostat Low-Dose Group DRUG

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

Low-Dose Group

Nafamostat High-Dose Group DRUG

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

High-Dose Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Interventions

nafamostat; Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Zhanguo Liu, M.D.PhD

  Department of Critical Care Medicine of Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhanguo Liu, M.D.PhD

CONTACT

+86-2062782927; zhguoliu@163.com

Zhanguo Liu, M.D.PhD

CONTACT

+86 020 62782927; zhguoliu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of critical care medicine, Principal Investigator

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 13, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)