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Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI - Trial NCT06375616

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.

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NCT06375616
Phase 4
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06375616
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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

Study Focus

Sepsis

Nafamostat Mesylate

Interventional

drug

Sponsor & Location

Shen Lei

Huashan Hospital

Shanghai, China

Timeline & Enrollment

Phase 4

Apr 01, 2024

Apr 01, 2027

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 sepsis
Sepsis, unspecified
Other specified sepsis
Candidal sepsis
Puerperal sepsis

Data Source

ClinicalTrials.gov

NCT06375616

Non-Device Trial