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

Septic Shock Clinical Trial

Official title:

Safety and Efficacy of Heparin Dosing Score Protocol for Anticoagulation During Polymyxin-B Hemoperfusion: a Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03177330
• Other study ID #: 201704033RIND
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2017
• Last updated: June 5, 2017
• Start date: May 15, 2017
• Est. completion date: July 2017

Study information

• Verified date: June 2017
• Source: National Taiwan University Hospital
• Contact: Chen-Tse Lee, MD
• Phone: +886972653169
• Email: lctbrian314[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Polymyxin B Hemoperfusion
• Septic Shock
• Shock, Septic

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, NTUH, Taipei, Taiwan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	premature cartridge clotting rate	the incidence of premature cartridge clotting within 2hr	2 hours
Secondary	bleeding event rate	the incidence of substantial bleeding event within 24hr	24 hours