Safety and Efficacy of Heparin Dosing Score Protocol for Polymyxin-B Hemoperfusion

• Conditions: Septic Shock; Polymyxin B Hemoperfusion

• Registration Number: NCT03177330
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Polymyxin B hemoperfusion (PMX-HP) is mainly used to remove endotoxins in septic shock patients with intra-abdominal infections. Because of the concerns of postoperative bleeding, physicians may hesitate to use anticoagulation in patients with septic shock within a few hours after an abdominal operation. We developed a heparin dosing score protocol for heparin dosage adjustment. The purpose of the study is to examine the safety and efficacy of the heparin dosing score protocol.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-15
• Status Verified: 2017-06
• Study First Submitted: 2017-06-04
• Study First Submitted QC: 2017-06-05
• Last Update Submitted: 2017-06-05
• Study First Posted: 2017-06-06
• Last Update Posted: 2017-06-06
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• intra-abdominal septic shock patients or documented Gram-negative bacterial septic shock patients who received polymyxin-B hemoperfusion in National Taiwan University Hospital during October 2013-December 2016

Exclusion Criteria

• pregnant woman
• patients with do-not-resuscitate declaration
• uncontrolled bleeding within 24hr

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
premature cartridge clotting rate	2 hours	the incidence of premature cartridge clotting within 2hr

Secondary Outcome Measures

Name	Time	Method
bleeding event rate	24 hours	the incidence of substantial bleeding event within 24hr

Trial Locations

Locations (1)

Department of Anesthesiology, NTUH, Taipei, Taiwan; 🇨🇳 Taipei, Taiwan