Nafamostat Mesilate for Anticoagulation During CRRT in Critically Ill Patients

NCT05382078 | Unknown

• 1 other identifier: XJTU1AF2022LSK-202
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the incidence of bleeding or massive hemorrhage events

  From date of first CRRT start until the date of discharge or death, assessed up to 90 days

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study plan to enroll 188 cases in 16 intensive care unit in Shaanxi province from January 2022 to December 2024.Patients will be divided into two group based on the anticoagulation method.1)Observation group: using NM as anticoagulant during CRRT；2)Control group: using heparins or RCA or anticoagulant-free during CRRT.

You may qualify if:

• Critically ill patients admitted to ICU
• ICU patients requiring further CRRT due to renal or non-renal indications
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• Tang-Du Hospital: collaborator
• Xi'an Gaoxin Hospital: collaborator
• Affiliated Chest Hospital Xi'an Jiaotong University: collaborator
• Xi'an Honghui Hospital: collaborator
• Shangluo Central Hospital: collaborator
• Yulin first Hospital: collaborator
• Yan'an University Affiliated Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Multiple Organ Failure; Hemorrhage; Wounds and Injuries; Thrombosis

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Qindong Shi, Chief

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Qindong Shi, Senior

CONTACT

0086-18991232391; shiqindong@163.com

Sha Sha, Junior

CONTACT

0086-18629560399; arztinss@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: May 19, 2022
• Study Start: May 31, 2022
• Primary Completion: May 4, 2023
• Study Completion: May 3, 2024
• Last Updated: May 19, 2022

Record last verified: 2022-04

Locations

CN (1)