Overview

This trial is active, not recruiting.

Conditions septic shock, endotoxemia
Treatment toraymyxin pmx-20r (pmx cartridge)
Phase phase 3
Sponsor Spectral Diagnostics (US) Inc.
Start date June 2010
End date July 2016
Trial size 450 participants
Trial identifier NCT01046669, SDI-PMX-NA001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Sham Comparator)
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).
(Experimental)
Two (2) PMX cartridges will be administered approximately 24 hours apart.
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).

Primary Outcomes

Measure
Mortality
time frame: 28 days

Secondary Outcomes

Measure
To compare mortality between the two groups at 90 days, 6 months and 12 months post-start of treatment
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Hypotension requiring vasopressor support - The subject must have received intravenous fluid resuscitation - Documented or suspected infection - Endotoxin Activity Assay ≥ 0.60 EAA units - Evidence of at least 1 new onset organ dysfunction Exclusion Criteria: - Inability to achieve or maintain a minimum mean arterial pressure (MAP) of 65mmHg - Subject has end stage renal disease and requires chronic dialysis - There is clinical support for non-septic shock - Subject has had chest compressions as part of CPR - Subject has had an acute myocardial infarction (AMI) - Subject has uncontrolled hemorrhage - Major trauma within 36 hours of screening - Subject has severe granulocytopenia - HIV infection with a last known or suspected CD4 count of <50/mm3 - Subject has sustained extensive third-degree burns - Body weight < 35 kg (77 pounds) - Known hypersensitivity to polymyxin B - Subject has known sensitivity or allergy to heparin - Subject has screening MOD score of ≤9

Additional Information

Official title Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock
Principal investigator Phillip Dellinger, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Spectral Diagnostics (US) Inc..