Nafamostat Mesilate for Anticoagulation During CRRT in Critically Ill Patients

Summary

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.

Conditions

• Sepsis Syndrome
• MODS
• AKI
• Hemorrhage
• Trauma
• Thrombus

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Xi'an Gaoxin Hospital

  collaborator OTHER

• Affiliated Chest Hospital Xi'an Jiaotong University

  collaborator UNKNOWN

• Xi'an Honghui Hospital

  collaborator OTHER

• Shangluo Central Hospital

  collaborator OTHER

• Yulin first Hospital

  collaborator UNKNOWN

• Yan'an University Affiliated Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  lead OTHER

Principal Investigators

• Qindong Shi, Chief · First Affiliated Hospital Xi'an Jiaotong University

Eligibility

Min Age

18 Years

Max Age

84 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-31

Primary Completion

2023-05-04

Completion

2024-05-03

Countries

• China

Study Locations