Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI
Sponsor: Shen Lei
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2024-04
Completion Date
2027-04
Last Updated
2024-04-19
Healthy Volunteers
No
Conditions
Interventions
Nafamostat Mesylate
During RRT, a priming dose of 20 mg of nafamostat mesylate (NM) is administered before initiation of the procedure. Upon starting the machine, there is no loading dose, but a maintenance infusion rate of 25 mg/h of NM is maintained. NM is discontinued in the last half hour before the end of the RRT session.
Unfractionated Heparin
During RRT, a priming dose of 50 mg of unfractionated heparin (UFH) is administered before initiation of the procedure. Upon starting the machine, a loading dose of 0.2 mg/kg of UFH is given, followed by a maintenance infusion rate of 0.1 mg/kg/h of UFH. The anticoagulant is discontinued in the last half hour before the end of the RRT session.
Locations (1)
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China