Blood Purification for the Treatment of Pathogen Associated Shock

Description

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

Conditions

Septic Shock

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Study Overview

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Study Details

Study overview

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

Blood Purification for the Treatment of Critically Ill Patients With Pathogen Associated Shock: A Multicenter, Randomized Controlled Feasibility Trial

Blood Purification for the Treatment of Pathogen Associated Shock

Condition
Septic Shock
Intervention / Treatment

-

Contacts and Locations

Washington

George Washington University, Washington, District of Columbia, United States, 20037

Brunswick

Southeast Georgia Health System, Inc., Brunswick, Georgia, United States, 31520

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Corvallis

Good Samaritan Hospital, Corvallis, Oregon, United States, 97330

Langhorne

Trinity Health Mid Atlantic-SMMC, Langhorne, Pennsylvania, United States, 19047

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390

San Antonio

Methodist Hospital, San Antonio, Texas, United States, 78229

San Antonio

University of Texas Health Science Center at San Antonio (UT Health San Antonio), San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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
  • 2. Male or non-pregnant female adult
  • 3. At least 18 years of age at time of enrollment
  • 1. Pregnant or breast feeding
  • 2. Anticipated transfer to another hospital (that is not a study site) within 72 hours for any reason
  • 3. Not anticipated to survive more than 24 hours
  • 4. Known allergy to heparin sodium
  • 5. Patients who cannot tolerate placement of double-lumen catheter
  • 6. 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)
  • 7. Inability to tolerate extracorporeal therapy (defined as MAP\<65 despite fluids and vasopressors)
  • 8. Advanced cancer (defined as stage IV) with life expectancy of less than 30 days
  • 9. Unable to obtain informed consent from either patient or legally authorized representative (LAR)
  • 10. Hypotension and volume depletion due to etiologies other than sepsis.
  • 11. Neutropenia with an absolute neutrophil count \<500mm3
  • 12. 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.
  • 13. 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".
  • 14. 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.
  • 15. Advanced directive for "Do Not Resuscitate".

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ExThera Medical Corporation,

Ian Stewart, MD, STUDY_CHAIR, Uniformed Services University of the Health Sciences

Study Record Dates

2025-09-30