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

N/ANot Yet RecruitingNCT06994312

The First Hospital of Jilin University282 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

282

Conditions

Sepsis-induced Coagulopathy (SIC)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults (Age ≥ 18 years); * Patients with SIC Undergoing Hemofiltration. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

ICU Mortality Rates

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