NCT06375616

Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI

A Comparative Study of Safety and Efficacy of Nafamostat Mesylate and Unfractionated Heparin in Renal Replacement Therapy for Sepsis Associated Acute Kidney Injury: A Randomized Controlled Trial
Shen Lei·Phase 4·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Sepsis
Drug/Device/Intervention
Nafamostat Mesylate
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shen Lei
Funder
Huashan Hospital
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 4
Start date
Apr 01, 2024
End date
Apr 01, 2027
Enrollment
156 participants
Primary outcome

Platelet decline rate

Summary

The goal of this clinical trial is to compare the safety and efficacy of nafamostat mesylate
 (NM) and unfractionated heparin (UFH) in the process of renal replacement therapy (RRT) for
 patients suffering from sepsis associated acute kidney injury (SA-AKI). The main questions it
 aims to answer are:
 
 The impact of NM and UFH on platelet count in septic patients undergoing RRT treatment.
 
 The satisfaction with anticoagulation of NM and UFH in septic patients undergoing RRT
 treatment.
 
 The 28-day all-cause mortality rate of septic patients undergoing RRT treatment with NM and
 UFH.
 
 Researchers will use NM or UFH as anticoagulation during RRT in SA-AKI patients, assessing
 effects on platelet count, anticoagulation satisfaction, and mortality.
 
 Participants will receive NM or UFH as anticoagulation during RRT for a minimum of 7 days.
 Bleeding symptoms, platelet count and coagulation function will be monitored daily. Platelet
 changes during the 7-day treatment period and survival status at 28 days post-treatment will
 be recorded.

ICD-10 classifications
Other sepsisSepsis, unspecifiedOther specified sepsisCandidal sepsisPuerperal sepsis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06375616
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06375616 through Pure Global AI's free database. This Phase 4 trial is sponsored by Shen Lei and is currently Not yet recruiting. The study focuses on Sepsis. Target enrollment is 156 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.