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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Spectral Diagnostics (US) Inc.
Sponsor:
Information provided by (Responsible Party):
Spectral Diagnostics (US) Inc.
ClinicalTrials.gov Identifier:
NCT01046669
First received: January 8, 2010
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Septic Shock
Endotoxemia
Device: TORAYMYXIN PMX-20R (PMX cartridge)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock

Resource links provided by NLM:


Further study details as provided by Spectral Diagnostics (US) Inc.:

Primary Outcome Measures:
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare mortality between the two groups at 90 days, 6 months and 12 months post-start of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: June 2010
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control 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).
Experimental: Treatment
Two (2) PMX cartridges will be administered approximately 24 hours apart.
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046669

Contacts
Contact: Debra Foster 416.626.3233 ext 2001 dfoster@spectraldx.com

  Show 41 Study Locations
Sponsors and Collaborators
Spectral Diagnostics (US) Inc.
Investigators
Principal Investigator: Phillip Dellinger, Dr. Cooper Health System
  More Information

No publications provided by Spectral Diagnostics (US) Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Spectral Diagnostics (US) Inc.
ClinicalTrials.gov Identifier: NCT01046669     History of Changes
Other Study ID Numbers: SDI-PMX-NA001
Study First Received: January 8, 2010
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Shock
Shock, Septic
Endotoxemia
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Bacteremia
Toxemia
Polymyxin B
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014