Blood Purification for the Treatment of Pathogen Associated Shock (NCT05011656) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Blood Purification for the Treatment of Pathogen Associated Shock
United States15 participantsStarted 2024-04-19
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Admitted to an ICU with pathogen associated shock defined as:
✓. Male or non-pregnant female adult
✓. At least 18 years of age at time of enrollment
Exclusion criteria
✕. 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)