Trauma Clinical Trial
— NMFADCICIPOfficial title:
Effectiveness and Safety Evaluation of Nafamostat Mesilate During Continuous Renal Replacement Therapy in Critically Ill Patients
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. Hemorrhageļ¼heparin-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.
Status | Not yet recruiting |
Enrollment | 188 |
Est. completion date | May 3, 2024 |
Est. primary completion date | May 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 84 Years |
Eligibility | Inclusion Criteria: - Critically ill patients admitted to ICU - ICU patients requiring further CRRT due to renal or non-renal indications - signed informed consent Exclusion Criteria: - The hospitalization stay of ICU is less than 24 hours. - The case data are incomplete. - age<18 and =85 - patients suffering from metal illness or unable to cooperate for some certain reasons - allergic to NM or Pharmaceutical excipient or extracorporeal circuit consumables - preparing for pregnancy/pregnant/ during lactation period - patients or their agents refuse to sign the informed consent form or participate in another clinical trial - non-compliant, lost visit or other situations that patients are unsuitable for selection determined by researchers |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Xian JiaotongUniversity | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University | Affiliated Chest Hospital Xi'an Jiaotong University, First Affiliated Hospital of Xi'an Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, Shangluo Central Hospital, Tang-Du Hospital, Xi'an Gaoxin Hospital, Xi'an Honghui Hospital, Yan'an University Affiliated Hospital, Yulin first Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the average filter life-span | The average filter life-span is calculated as the total life-span of filters devided by filter numbers during the first 96 hours of first CRRT. The metric is described as hour per number. | up to 96 hours | |
Secondary | the incidence of bleeding or massive hemorrhage events | This indication is to describe the safety of NM. The incident rate of bleeding or hemorrhage will be counted and calculated to compare the difference between groups. | From date of first CRRT start until the date of discharge or death, assessed up to 90 days |
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