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

NCT06375616 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2024-04-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Shen Lei

    lead OTHER

Principal Investigators

  • Lei Shen, MD · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375616 on ClinicalTrials.gov