Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 9, 2020

Primary Completion Date

May 8, 2025

Study Completion Date

April 30, 2026

Conditions
Septic ShockEndotoxemia
Interventions
DEVICE

Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge

TORAYMYXIN PMX-20R (PMX) is an extracorporeal hemoperfusion cartridge intended for the selective removal of endotoxin from circulating blood through direct hemoperfusion (DHP). 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).

Trial Locations (20)

10029

Mt Sinai Hospital, New York

11794

Stony Brook University, Stony Brook

15213

UPMC, Pittsburgh

20037

George Washington University, Washington D.C.

29425

Medical University of South Carolina, Charleston

30322

Emory University, Atlanta

37404

CHI Memorial, Chattanooga

Parkridge Hospital, Chattanooga

48109

University of Michigan, Ann Arbor

55905

Mayo Clinic, Rochester

71103

Louisiana State University Health Shreveport, Shreveport

72205

University of Arkansas for Medical Sciences, Little Rock

77030

The University of Texas Health Science Center at Houston, Houston

78229

Institute for Extracorporeal Life Support, San Antonio

80909

Pulmonary Associates, Boulder

94143

University of California, San Francisco, San Francisco

35294-0111

University of Alabama at Birmingham, Birmingham

01199

Baystate Medical Center, Springfield

08103

Cooper Health System, Camden

08854

Rutgers, The State University of New Jersey, Piscataway

All Listed Sponsors
lead

Spectral Diagnostics (US) Inc.

INDUSTRY