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OpenTrials
Completed

NCT Number: NCT01046669

Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock

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.

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Key information

Conditions

Septic Shock Bacteremia Endotoxemia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 shock

Other

Standard medical care for septic shock

Primary outcomes

  1. Mortality

    Time frame: 28 days

    Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone

Sponsors and collaborators

Lead sponsor

Spectral Diagnostics (US) Inc.

Industry

Registry information

Official study title

Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock

Acronym: EUPHRATES

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Jan 12, 2010
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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