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

S

Spectral Diagnostics

Status

Completed

Conditions

Endotoxemia
Septic Shock

Treatments

Device: TORAYMYXIN PMX-20R (PMX cartridge)
Other: Standard medical care for septic shock

Study type

Interventional

Funder types

Industry

Identifiers

NCT01046669
SDI-PMX-NA001

Details and patient eligibility

About

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.

Enrollment

450 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

450 participants in 2 patient groups

Control
Sham Comparator group
Description:
Standard medical care for septic shock
Treatment:
Other: Standard medical care for septic shock
Treatment
Experimental group
Description:
Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock
Treatment:
Other: Standard medical care for septic shock
Device: TORAYMYXIN PMX-20R (PMX cartridge)

Trial contacts and locations

40

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Data sourced from clinicaltrials.gov

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