Blood purification treatment for septic shock

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

This study is testing a new blood purification treatment to see if it can help critically ill adults with septic shock feel better when combined with standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ExThera Medical Corporation (Industry-sponsored)
• Locations: 9 sites (Washington, District of Columbia and 8 other locations)
• Trial ID: NCT05011656 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized controlled feasibility trial evaluates the safety and efficacy of a novel extracorporeal blood purification therapy, Seraph 100, in critically ill patients suffering from pathogen associated shock. Participants will be randomly assigned to receive either the investigational treatment along with standard care or standard care alone. The study focuses on adults admitted to the ICU who require vasopressors to maintain blood pressure despite adequate fluid resuscitation and have a pathogen detected in their bloodstream. The trial will be conducted across 15 sites in the U.S. and will not be blinded due to the nature of the treatment and necessary procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are admitted to the ICU with pathogen associated shock requiring vasopressors.

Not a fit: Patients who are pregnant, have a high risk of bleeding, or are not expected to survive more than 24 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and outcomes for patients with septic shock.

How similar studies have performed: While this approach is novel, similar studies exploring extracorporeal therapies for septic shock have shown promising results.

Eligibility criteria

Inclusion 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

Exclusion Criteria:

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".

Where this trial is running

Washington, District of Columbia and 8 other locations

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

Study contacts

• Study coordinator: Lakhmir Chawla, M.D.

Conditions Septic Shock; pathogen associated shock