Viewing Study NCT02871024



Ignite Creation Date: 2024-05-06 @ 8:59 AM
Last Modification Date: 2024-10-26 @ 12:08 PM
Study NCT ID: NCT02871024
Status: TERMINATED
Last Update Posted: 2019-03-28
First Post: 2016-08-04

Brief Title: Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection A Single-arm Clinical Trial
Status: TERMINATED
Status Verified Date: 2019-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Difficult recruitment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized fiber column designed to reduce blood endotoxin levels in sepsis Meta-analysis of randomized trials showed that polymyxin B hemoperfusion significantly reduced the mortality of severe sepsis however the evidence was mainly contributed by the studies of abdominal sepsis The data about using polymyxin B hemoperfusion to treat non-abdominal sepsis remain very limited Investigators designed a clinical trial to evaluate the efficacy of polymyxin B hemoperfusion on treating non-abdominal severe sepsis The study hypothesis is that removal of endotoxin by polymyxin B hemoperfusion in patients with pneumonia or urinary tract infection UTI-related severe sepsis will attenuate sepsis associated microcirculation failure and result in early reversal of shock and less extent of end-organ damage
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None