Sepsis-induced Coagulopathy (SIC)
Conditions
Keywords
Single-Center, Prospective, Randomized Controlled Trial, sepsis-induced coagulopathy (SIC), Nafamostat Mesylate, Prognosis, Hemofiltration
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.
Interventions
Anticoagulation with Nafamostat Mesylate for SIC Patients Undergoing Hemofiltration
DRUGsodium citrate
Anticoagulation with Sodium Citrate for SIC Patients Undergoing Hemofiltration
Sponsors
The First Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU Mortality Rates | Through study completion, an average of 1 year | The proportion of patients who died during the ICU stay out of the total number of patients in the group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Filter Lifespan | Through study completion, an average of 1 year | The total sum of all filter usage times for each patient divided by the number of filters used. |
| ICU length of stay | Through study completion, an average of 1 year | Length of Stay in the ICU |
| 28-day mortality | Through study completion, an average of 1 year | The proportion of patients who died within 28 days out of the total number of patients in the group. |
| Incidence of Bleeding | Through study completion, an average of 1 year | The proportion of patients experiencing bleeding events (such as cerebral hemorrhage, gastrointestinal bleeding, etc.) during the ICU stay out of the total number of patients. |
Outcome results
None listed