The Impact of Nafamostat Mesylate on the Prognosis of Patients With Sepsis-Induced Coagulopathy Undergoing Hemofiltration

NCT06994312 | Not Yet Recruiting

• 1 other identifier: Yuting Li 20250430
• Study Type: interventional
• Target: 282
• Locations: 0 countries
• Sites: N/A

Brief Summary

In sepsis, the body is prone to coagulation system disorders, which may progress to sepsis-induced coagulopathy (SIC). When SIC is persistent and cannot be corrected, it often sequentially develops into disseminated intravascular coagulation (DIC) with multiple organ failure. Nafamostat mesylate can be used as an anticoagulant during blood purification in critically ill patients and is also used to treat SIC.Safe and effective anticoagulation is a prerequisite for the success of blood purification therapy. For patients with active bleeding or at risk of bleeding, how to achieve extracorporeal anticoagulation without affecting the body's coagulation function is a major clinical challenge. Nafamostat mesylate can reduce the risk of bleeding during blood purification, but its impact on the survival outcomes of patients with SIC undergoing blood purification therapy remains unclear.The aim of this study is to evaluate the impact of nafamostat mesylate treatment on the prognosis of patients with sepsis-induced coagulopathy undergoing hemofiltration.

Conditions

Sepsis-induced Coagulopathy (SIC)

Keywords

Single-Center, Prospective, Randomized Controlled Trial; sepsis-induced coagulopathy (SIC); Nafamostat Mesylate; Prognosis; Hemofiltration

Outcome Measures

Primary Outcomes (1)

• ICU Mortality Rates

  The proportion of patients who died during the ICU stay out of the total number of patients in the group.

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• Average Filter Lifespan

  Through study completion, an average of 1 year

• ICU length of stay

  Through study completion, an average of 1 year

• 28-day mortality

  Through study completion, an average of 1 year

• Incidence of Bleeding

  Through study completion, an average of 1 year

Study Arms (2)

Nafamostat Mesylate Group

EXPERIMENTAL

Nafamostat mesylate (50 mg/vial, Jiangsu DuRui Pharmaceutical Co., Ltd.) is dissolved and prepared with 5% glucose injection solution. It is continuously infused through the anticoagulant injection tube at the start of hemofiltration, with an initial dose generally ranging from 20 to 50 mg/h. Monitoring is performed before treatment and within 2 to 4 hours after the start of treatment. In cases of active bleeding, moderate to high bleeding risk, hypercoagulable state, or high-dose use of nafamostat mesylate (NM), the monitoring frequency should be increased (e.g., every 4 to 6 hours). After the treatment becomes stable, the monitoring interval can be extended to 12 to 24 hours. The activated clotting time (ACT) or activated partial thromboplastin time (APTT) at the post-dialyzer or venous end should be maintained at 1.5 to 2.5 times the pre-treatment level, or the ACT should be maintained between 150 and 250 seconds, and the APTT between 50 and 70 seconds.

Drug: Nafamostat Mesylate

Sodium Citrate Group

ACTIVE COMPARATOR

Patients were continuously infused with sodium citrate (200 ml/bag, Chengdu Qingshanlikang Pharmaceutical Co., Ltd.). The initial pump rate of 4% sodium citrate was set at 2.1% of the blood flow rate, and the initial pump rate of 10% calcium gluconate was set at 7.3% of the flow rate of 4% sodium citrate. Adjust the doses of sodium citrate and calcium gluconate based on the levels of ionized calcium in arterial and venous blood gases.The goal is to maintain arterial blood ionized calcium levels at 1.00-1.20 mmol/L and venous blood ionized calcium levels at 0.21-0.40 mmol/L.

Drug: sodium citrate

Interventions

Nafamostat Mesylate DRUG

Anticoagulation with Nafamostat Mesylate for SIC Patients Undergoing Hemofiltration

Also known as: Experimental Group

Nafamostat Mesylate Group

sodium citrate DRUG

Anticoagulation with Sodium Citrate for SIC Patients Undergoing Hemofiltration

Also known as: Control Group

Sodium Citrate Group

Eligibility Criteria

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

You may qualify if:

• Adults (Age ≥ 18 years);
• Patients with SIC Undergoing Hemofiltration.

You may not qualify if:

• Individuals under the age of 18, pregnant women, and breastfeeding mothers;
• Patients with a history of high sensitivity to nafamostat mesylate (those who have experienced significant bleeding complications from previous use of nafamostat mesylate);
• Fibrinogen \< 1.5 g/L;
• Patients with bleeding or high risk of bleeding:
• Those in the acute phase of trauma or with active bleeding (e.g., flail chest, obvious contusions of the lungs, liver, spleen, retroperitoneal bleeding, pelvic fractures, etc.); Those with a history of severe head trauma, intracranial surgery, stroke, cerebral aneurysm, or arteriovenous malformation within one month prior to enrollment; Those with a history of congenital bleeding disorders: such as hemophilia; Those with underlying fulminant hepatitis, decompensated cirrhosis, or other severe liver diseases.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Interventions

nafamostat; Sodium Citrate; Control Groups

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 29, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share