Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI (NCT06375616) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI
China156 participantsStarted 2024-04
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 14 years old, and ≤ 90 years old.
* Sepsis or septic shock.
* AKI (Acute Kidney Injury), with stage of 2-3.
* Received renal replacement therapy (RRT) for ≥ 24 hours.
* Survival time ≥ 48 hours.
Exclusion Criteria:
* Presence of bleeding tendency or active bleeding.
* Pre-existing chronic kidney disease or already undergoing routine hemodialysis.
* With liver failure, severe hematologic disorders, malignancies, or other significant underlying diseases
* Pre-using of anticoagulant or antiplatelet medications such as aspirin, clopidogrel, rivaroxaban, dabigatran, or ticagrelor
* Allergy to heparin or nafamostat mesylate.
* Survival time \< 48 hours or RRT treatment time \< 24 hours.
* Initial platelet count \< 50 × 10\^9/L.
* Participation in another clinical trial within the past 1 month.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Platelet decline rate
Timeframe: 7 days after initiation of RRT treatment