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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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