Continuous Renal Replacement Therapy (CRRT)Phase 2NCT07469072
Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU)
A Phase 2 study testing Nafamostat Low-Dose Group and Nafamostat High-Dose Group in people with Continuous Renal Replacement Therapy (CRRT), run by Zhujiang Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Continuous Renal Replacement Therapy (CRRT)
- What is being tested?
- Nafamostat Low-Dose Group and Nafamostat High-Dose Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2026to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, 510282
Zhanguo Liu, +86 020 62782927, zhguoliu@163.com
About this study
Official title: 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
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.
Read the detailed description
Investigational drug: Nafamostat Mesilate for Injection Study title: Comparison of Anticoagulation Efficacy of Different Doses of Nafamostat Mesilate during Continuous Renal Replacement Therapy in ICU: A Single-Center, Randomized, Open-Label, Parallel-Controlled Clinical Trial Principal Investigator: Zhanguo Liu, Professor, Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University Study subjects: Patients aged 18-80 years admitted to the ICU requiring Continuous Renal Replacement Therapy (CRRT) for ≥24 hours, with normal coagulation function (INR ≤1.5, Fibrinogen ≥1.5 g/L, APTT ≤45 s), platelet count ≥50 G/L, and BMI between 18.5 and 25 kg/m². Patients with known allergy to Nafamostat, active bleeding, pregnancy, or those using other systemic anticoagulants or extracorporeal devices (e.g., ECMO, IABP) are excluded.
Study objectives: The primary objective is to determine whether a high initial dose (50 mg/h) of Nafamostat Mesilate, compared to a low initial dose (20 mg/h), prolongs the filter lifespan in ICU patients undergoing CRRT. Secondary objectives include evaluating differences in transmembrane pressure, clotting events, CRRT duration, blood flow rates, delivered dose, and safety outcomes such as bleeding complications and adverse drug reactions.
Study design: A single-center, randomized, open-label, parallel-controlled clinical trial.
Method: Eligible patients will be randomized into two groups:Low-Dose Group (Group A): Receives Nafamostat Mesilate at an initial continuous infusion dose of 20 mg/h pre-filter.High-Dose Group (Group B): Receives Nafamostat Mesilate at an initial continuous infusion dose of 50 mg/h pre-filter.
In both groups, the dosage will be titrated in increments of 5 or 10 mg/h based on activated clotting time (ACT) and activated partial thromboplastin time (APTT) measured post-filter. The target is to maintain post-filter ACT at 150-250 s (or 2.5 times baseline) and APTT at 50-70 s, while ensuring pre-filter values do not exceed 1.5 times baseline. The intervention continues until CRRT discontinuation due to filter clotting, recovery, transfer, death, or bleeding. Standardized CRRT protocols (CVVH mode, blood flow 150-200 mL/min) and routine critical care treatments are applied to all patients.
Course: Up to 72 hours per filter session, or until CRRT discontinuation. Sample size: 92 patients (46 per group). The number of study centers: 1 Study center:Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China Primary endpoint:Filter Lifespan: Defined as the duration (in hours) from the initiation of Nafamostat anticoagulation to filter change or discontinuation of CRRT due to clotting, extended downtime, renal recovery, patient transfer/death, or bleeding events necessitating a change in anticoagulation strategy.
Secondary endpoints:Filter Performance: Changes in Transmembrane Pressure (TMP) at specified intervals (2h, 8h, 16h, 24h, etc.); Number of filter clotting events (defined as TMP >250 mmHg or visible clotting).
Treatment Metrics: Total CRRT duration; Average daily blood flow rate; Daily delivered CRRT dose.
Coagulation Parameters: Maintenance levels of ACT and APTT; Changes in hemoglobin and platelet counts.
Safety Outcomes: Incidence of bleeding complications (e.g., gingival bleeding, epistaxis, GI bleeding); Incidence of adverse drug reactions related to Nafamostat (e.g., rash, hyperkalemia, elevated liver enzymes, gastrointestinal symptoms); Total blood product transfusion volume during CRRT.
Safety endpoints:Adverse Events: Monitoring for specific adverse reactions including drug allergy (rash), hyperkalemia, elevated AST/ALT, bleeding, thrombocytopenia, and gastrointestinal symptoms (nausea, vomiting, diarrhea).
Serious Adverse Events (SAE): Recording any event leading to death, life-threatening conditions, prolonged hospitalization, or significant disability, assessed for causality with the study drug.
- Being tested
- Nafamostat Low-Dose Group, Nafamostat High-Dose Group
- Keywords
- Continuous Renal Replacement Therapy (CRRT), Anticoagulation Efficacy, Nafamostat Mesilate (NM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nafamostat Low-Dose GroupDrug
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 GroupDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nafamostat High-Dose Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From hour 0 (initiation of anticoagulation) to hour 72 (end of Day 3), with assessments at predefined hourly intervals.
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.
Measured: From baseline (initiation of CRRT) up to 72 hours post-baseline, or until filter replacement/discontinuation, whichever occurs first.
Duration of CRRT
The total duration of the CRRT treatment session. Data obtained from nursing records and medical charts.
Measured: From baseline (initiation of CRRT) up to 72 hours post-baseline, or until filter replacement/discontinuation, whichever occurs first.
Delivered CRRT Dose
The actual delivered dose of CRRT treatment. Data obtained from nursing records and medical charts.
Measured: From initiation of CRRT until filter replacement or discontinuation, up to a maximum of 72 hours per session.
Activated Partial Thromboplastin Time (APTT)
APTT measured from peripheral venous blood. Data obtained from laboratory test results.
Measured: 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).
Prothrombin Time (PT)
PT measured from peripheral venous blood. Data obtained from laboratory test results.
Measured: 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).
Fibrinogen (FIB)
FIB measured from peripheral venous blood. Data obtained from laboratory test results.
Measured: 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).
Activated Clotting Time (ACT)
ACT levels indicating systemic coagulation status and CRRT anticoagulation effect. Data obtained from laboratory test results.
Measured: Pre-medication baseline, followed by assessments at 2hours, 8hours, 16hours, 24hours, 32hours, 40hours, 48hours, 56hours, 64hours, and 72hours post-initiation of anticoagulation.
Hemoglobin Level
Hemoglobin concentration measured from peripheral venous blood to assess anemia and guide transfusion timing during CRRT. Data obtained from laboratory test results.
Measured: Before medication, Day 1, Day 2, and Day 3 after medication.
Platelet Count
Platelet count measured from peripheral venous blood to assess bleeding risk and monitor thrombocytopenia during CRRT. Data obtained from laboratory test results.
Measured: Before medication, Day 1, Day 2, and Day 3 after medication.
Incidence of Bleeding Complications
Observation of bleeding manifestations such as gingival bleeding, epistaxis, skin ecchymosis, and gastrointestinal bleeding during CRRT. Data obtained from physician reports, nursing documents, and medical charts.
Measured: From baseline (initiation of CRRT) up to 72 hours post-baseline, or until filter replacement/discontinuation, whichever occurs first.
Adverse Drug Reactions Related to Nafamostat
Includes drug allergy (rash), hyperkalemia, elevated AST/ALT, bleeding, decreased platelets, and gastrointestinal symptoms (nausea, vomiting, diarrhea). Data obtained from physician reports, nursing documents, and medical charts.
Measured: From initiation of Nafamostat Mesilate up to 72 hours post-initiation.
Blood Transfusion Volume During Nafamostat-Anticoagulated CRRT
Total volume of blood or blood components (e.g., red blood cells, platelets, fresh frozen plasma, cryoprecipitate) transfused during the CRRT treatment period with Nafamostat anticoagulation. Data obtained from physician reports, nursing documents, and medical charts.
Measured: From baseline (initiation of CRRT) up to 72 hours post-baseline, or until filter replacement/discontinuation, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start7 Apr 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Renal Replacement Therapy (CRRT)Studies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhanguo, Zhujiang Hospital
- Investigators
- Zhanguo Liu, M.D.PhD, Principal investigator, Department of Critical Care Medicine of Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469072
- Sponsor's protocol ID
- 2025-KY-539-01
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since some data may involve patients privacy. We have no plans to share data so far, and some data may be shared later depending on the patient's wishes.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07469072
- Acronym / sponsor ID
- 2025-KY-539-01
- Keywords
- Continuous Renal Replacement Therapy (CRRT), Anticoagulation Efficacy, Nafamostat Mesilate (NM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Investigational drug: Nafamostat Mesilate for Injection Study title: Comparison of Anticoagulation Efficacy of Different Doses of Nafamostat Mesilate during Continuous Renal Replacement Therapy in ICU: A Single-Center, Randomized, Open-Label, Parallel-Controlled Clinical Trial Principal Investigator: Zhanguo Liu, Professor, Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University Study subjects: Patients aged 18-80 years admitted to the ICU requiring Continuous Renal Replacement Therapy (CRRT) for ≥24 hours, with normal coagulation function (INR ≤1.5, Fibrinogen ≥1.5 g/L, APTT ≤45 s), platelet count ≥50 G/L, and BMI between 18.5 and 25 kg/m². Patients with known allergy to Nafamostat, active bleeding, pregnancy, or those using other systemic anticoagulants or extracorporeal devices (e.g., ECMO, IABP) are excluded.
Study objectives: The primary objective is to determine whether a high initial dose (50 mg/h) of Nafamostat Mesilate, compared to a low initial dose (20 mg/h), prolongs the filter lifespan in ICU patients undergoing CRRT. Secondary objectives include evaluating differences in transmembrane pressure, clotting events, CRRT duration, blood flow rates, delivered dose, and safety outcomes such as bleeding complications and adverse drug reactions.
Study design: A single-center, randomized, open-label, parallel-controlled clinical trial.
Method: Eligible patients will be randomized into two groups:Low-Dose Group (Group A): Receives Nafamostat Mesilate at an initial continuous infusion dose of 20 mg/h pre-filter.High-Dose Group (Group B): Receives Nafamostat Mesilate at an initial continuous infusion dose of 50 mg/h pre-filter.
In both groups, the dosage will be titrated in increments of 5 or 10 mg/h based on activated clotting time (ACT) and activated partial thromboplastin time (APTT) measured post-filter. The target is to maintain post-filter ACT at 150-250 s (or 2.5 times baseline) and APTT at 50-70 s, while ensuring pre-filter values do not exceed 1.5 times baseline. The intervention continues until CRRT discontinuation due to filter clotting, recovery, transfer, death, or bleeding. Standardized CRRT protocols (CVVH mode, blood flow 150-200 mL/min) and routine critical care treatments are applied to all patients.
Course: Up to 72 hours per filter session, or until CRRT discontinuation. Sample size: 92 patients (46 per group). The number of study centers: 1 Study center:Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China Primary endpoint:Filter Lifespan: Defined as the duration (in hours) from the initiation of Nafamostat anticoagulation to filter change or discontinuation of CRRT due to clotting, extended downtime, renal recovery, patient transfer/death, or bleeding events necessitating a change in anticoagulation strategy.
Secondary endpoints:Filter Performance: Changes in Transmembrane Pressure (TMP) at specified intervals (2h, 8h, 16h, 24h, etc.); Number of filter clotting events (defined as TMP >250 mmHg or visible clotting).
Treatment Metrics: Total CRRT duration; Average daily blood flow rate; Daily delivered CRRT dose.
Coagulation Parameters: Maintenance levels of ACT and APTT; Changes in hemoglobin and platelet counts.
Safety Outcomes: Incidence of bleeding complications (e.g., gingival bleeding, epistaxis, GI bleeding); Incidence of adverse drug reactions related to Nafamostat (e.g., rash, hyperkalemia, elevated liver enzymes, gastrointestinal symptoms); Total blood product transfusion volume during CRRT.
Safety endpoints:Adverse Events: Monitoring for specific adverse reactions including drug allergy (rash), hyperkalemia, elevated AST/ALT, bleeding, thrombocytopenia, and gastrointestinal symptoms (nausea, vomiting, diarrhea).
Serious Adverse Events (SAE): Recording any event leading to death, life-threatening conditions, prolonged hospitalization, or significant disability, assessed for causality with the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Group | Experimental | Drug: Nafamostat Low-Dose GroupThe 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. |
| High-Dose Group | Experimental | Drug: Nafamostat High-Dose GroupThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nafamostat Low-Dose GroupNafamostat 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 | Drug | Low-Dose Group |
| Nafamostat High-Dose GroupNafamostat 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 | Drug | High-Dose Group |
Primary outcome
Filter Lifespan
Time frame: 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.
13 secondary outcomes
Filter Transmembrane Pressure (TMP) Changes
Time frame: From hour 0 (initiation of anticoagulation) to hour 72 (end of Day 3), with assessments at predefined hourly intervals.
Incidence of Filter Clotting Events
Time frame: From baseline (initiation of CRRT) up to 72 hours post-baseline, or until filter replacement/discontinuation, whichever occurs first.
Duration of CRRT
Time frame: From baseline (initiation of CRRT) up to 72 hours post-baseline, or until filter replacement/discontinuation, whichever occurs first.
Delivered CRRT Dose
Time frame: From initiation of CRRT until filter replacement or discontinuation, up to a maximum of 72 hours per session.
Activated Partial Thromboplastin Time (APTT)
Time frame: 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).
Prothrombin Time (PT)
Time frame: 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).
Fibrinogen (FIB)
Time frame: 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).
Activated Clotting Time (ACT)
Time frame: Pre-medication baseline, followed by assessments at 2hours, 8hours, 16hours, 24hours, 32hours, 40hours, 48hours, 56hours, 64hours, and 72hours post-initiation of anticoagulation.
Hemoglobin Level
Time frame: Before medication, Day 1, Day 2, and Day 3 after medication.
Platelet Count
Time frame: Before medication, Day 1, Day 2, and Day 3 after medication.
Incidence of Bleeding Complications
Time frame: From baseline (initiation of CRRT) up to 72 hours post-baseline, or until filter replacement/discontinuation, whichever occurs first.
Adverse Drug Reactions Related to Nafamostat
Time frame: From initiation of Nafamostat Mesilate up to 72 hours post-initiation.
Blood Transfusion Volume During Nafamostat-Anticoagulated CRRT
Time frame: From baseline (initiation of CRRT) up to 72 hours post-baseline, or until filter replacement/discontinuation, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. Since some data may involve patients privacy. We have no plans to share data so far, and some data may be shared later depending on the patient's wishes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhanguo Liu, M.D.PhD principal investigator
Department of Critical Care Medicine of Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nafamostat Low-Dose Group and Nafamostat High-Dose Group in people with Continuous Renal Replacement Therapy (CRRT), run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhanguo Liu, M.D.PhD (+86-2062782927, zhguoliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Filter Lifespan (time frame: From the initiation of Nafamostat Mesilate anticoagulation until filterreplacement or discontinuation of CRRT (up to 72 hours per filter session).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.