Blood Purification for the Treatment of Pathogen Associated Shock

Running, not enrolling · Not applicable

Conditions studied: Septic Shock

In brief

This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock across 15 U.S. sites. Adults (18 years old and older) admitted to the ICU with all of the following: • Pathogen associated shock defined as: * The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation * Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing

Key facts

Study ID: NCT05011656
Run by: ExThera Medical Corporation
People needed: 15
Starts: 2024-04-19
Expected to finish: 2027-07-31
Last updated by the study team: 2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Admitted to an ICU with pathogen associated shock defined as:
The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation, AND
Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing
Male or non-pregnant female adult
At least 18 years of age at time of enrollment

You may not qualify if…

Pregnant or breast feeding
Anticipated transfer to another hospital (that is not a study site) within 72 hours for any reason
Not anticipated to survive more than 24 hours
Known allergy to heparin sodium
Patients who cannot tolerate placement of double-lumen catheter
High risk of bleeding (platelet count <50mm3 or International Normalized Ratio (INR) >2) unless adequate line for treatment already placed (e.g. ECMO or RRT/CRRT)
Inability to tolerate extracorporeal therapy (defined as MAP<65 despite fluids and vasopressors)
Advanced cancer (defined as stage IV) with life expectancy of less than 30 days
Unable to obtain informed consent from either patient or legally authorized representative (LAR)
Hypotension and volume depletion due to etiologies other than sepsis.
Neutropenia with an absolute neutrophil count <500mm3
Patients must be treated with one of the antimicrobial agents listed in the Antimicrobial Management Guideline (Table 19). Patients who require treatment with an antimicrobial outside of this list while still receiving treatment with the investigational device must be excluded from the study.
If a patient enters the study and later requires a change in the antimicrobial agent used to one which is not listed in the Antimicrobial Management Guideline while still receiving treatment with the investigational device, that patient must be removed from this trial. Clinical data for any patient removed from the trial for this reason will continue to be collected for safety evaluation".
Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or IRB/ethics committee.
Advanced directive for "Do Not Resuscitate".

Where it is running

George Washington University — Washington D.C., District of Columbia, United States
Southeast Georgia Health System, Inc. — Brunswick, Georgia, United States
University of Michigan — Ann Arbor, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
Good Samaritan Hospital — Corvallis, Oregon, United States
Trinity Health Mid Atlantic-SMMC — Langhorne, Pennsylvania, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States
Methodist Hospital — San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio (UT Health San Antonio) — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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