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

Septic Shock Clinical Trial

— EUPHRATES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046669
• Other study ID #: SDI-PMX-NA001
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: June 2017

Study information

• Verified date: February 2019
• Source: Spectral Diagnostics (US) Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: June 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endotoxemia
• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• TORAYMYXIN PMX-20R (PMX cartridge)
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).

Other:
• Standard medical care for septic shock
Standard medical care for septic shock

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spectral Diagnostics (US) Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone	28 days