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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Kianoush Kashani, M.D., M.S.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Kianoush Kashani, M.D., M.S.

Closed for enrollment

More information

Publications

Publications are currently not available

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