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NCT05382078: NMFADCICIP
Nafamostat Mesilate for Anticoagulation During CRRT in Critically Ill Patients
trial in Sepsis Syndrome in 188 participants. Status unknown.
4 May 2023
Quick facts
| Lead sponsor | First Affiliated Hospital Xi'an Jiaotong University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 188 |
| Start date | 31 May 2022 |
| Primary completion | 4 May 2023 |
| Estimated completion | 3 May 2024 |
| Sites | 1 location across China |
Conditions studied
- Sepsis Syndrome — all drugs for Sepsis Syndrome →
- MODS — all drugs for MODS →
- AKI — all drugs for AKI →
- Hemorrhage — all drugs for Hemorrhage →
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Who can join
Adults 18 to 84, any sex, with Sepsis Syndrome or MODS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Continuous renal replacement therapy is widely used in intensive care medicine, which is known as an alternative therapy to save injured kidney . Anticoagulation is an important part of this therapy. An insufficient anticoagulation would cause a poor curative effect of CRRT. Hemorrhage，heparin-induced thrombocytopenia (HIT), citrate accumulation, acidosis ad filter extra-cost usually happened on anticoagulation during CRRT. Therefore a new effective anticoagulation of CRRT needs to be carried out. Nafamostat Mesylate (NM) is a new anticoagulant. This serine protease inhibitor with broad spectrum can inhibit kinds of enzymes on the process of coagulation. NM is mainly rapidly decomposed in the liver and also removed by dialysis or filtration. The elimination half life of is only 8 minutes. If NM is applied as a regional anticoagulant, approximate 40% NM is removed by dialysis and / or convection in cardiopulmonary bypass circuit, and then rapidly degraded by esterase in liver and blood, which ensures security in patients with bleeding tendency. Based on the information above, the investigators designed an observational clinical study aimed to testify that NM would have equivalent anticoagulant results compared with those traditional ways and might even have a better effect than traditional anticoagulant therapy.The study team has investigated the current situation of CRRT in Shaanxi province in China through a cross-sectional survey last year. The survey involved 74 hospitals in Shaanxi province and the results basically illustrated a real status of CRRT. These scientific results helped investigators to design this multi-center, parallel, controlled, non intervention study and real world study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05382078
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05382078 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital Xi'an Jiaotong University
- Last refreshed: 19 May 2022
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