CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 450 enrolled
Drug / intervention
TORAYMYXIN PMX-20R (PMX cartridge) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01046669
NCT01046669N/ACompleted
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Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock

Spectral Diagnostics (US) Inc.·interventional·Posted Jan 12, 2010·Updated Feb 26, 2019

In Brief

A clinical study evaluating TORAYMYXIN PMX-20R (PMX cartridge) and Standard medical care for septic shock for Septic Shock and Endotoxemia. Completed, enrolled 450 participants across 40 sites in 2 countries.

Detailed Summary

To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock, Endotoxemia
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 12, 2010
Enrollment StartJun 1, 2010
Primary CompletionJul 1, 2016
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 16.5 years ago

Interventions

TORAYMYXIN PMX-20R (PMX cartridge)device

TORAYMYXIN PMX-20R (PMX cartridge), Extracorporeal hemoperfusion device. Each treatment will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 ml/minute, (range of 80 to 120 ml/minute).

Standard medical care for septic shockother

Standard medical care for septic shock