Hemoperfusion Efferon LPS During Cardiac Surgery Using Cardiopulmonary Bypass (NCT06659289) | Clinical Trial Compass
TerminatedNot Applicable
Hemoperfusion Efferon LPS During Cardiac Surgery Using Cardiopulmonary Bypass
Stopped: Terminated due to futility. Post-enrollment analysis of baseline disease severity indicated that the enrolled population would not allow for a meaningful assessment of the treatment effect on the primary endpoint.
Russia14 participantsStarted 2024-11-11
Plain-language summary
More than 1 million people undergo cardiac surgery each year worldwide. Cardiac surgeries still in most cases require cardiopulmonary bypass, use of myocardial protection against aortic clamping and creation of cardioplegic arrest of the heart by injecting cardioplegic solutions into the coronary bed. All of the above is a source of myocardial ischemia-reperfusion injury, which remains the leading cause of acute heart failure in the period after the return of spontaneous circulation and, as a consequence, the development of post-perfusion multiple organ dysfunction syndrome and, in particular, acute kidney injury (AKI). Acute kidney injury typically develops in 7% of all hospitalised patients, 30% of intensive care unit patients and 30% of cardiac surgery patients. Endotoxemia is a major cause of AKI. Septic AKI (compared to non-septic AKI) is associated with a worse prognosis, longer hospital stay and poorer survival.
The use of the Efferon LPS hemoperfusion device, which has proven efficacy in removing not only endotoxin but also cytokines, may be promising in preventing the development of multiple organ dysfunction syndrome and in particular AKI in patients after cardiac surgery with cardiopulmonary bypass.
Who can participate
Age range
18 Years – 75 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:
* Planned cardiac surgery (aortocoronary bypass, heart valve replacement, etc.) requiring the use of cardiopulmonary bypass
Exclusion Criteria:
* Emergency nature of cardiac surgery
* Cases in which a surgical procedure is required in addition to an aortocoronary artery bypass graft operation
* History of aortocoronary bypass surgery
* History of hemato-oncology
* Receiving immunosuppressive therapy for cancer and autoimmune diseases
* Sepsis, acute heart failure, acute respiratory failure, acute kidney injury at the time of enrolment
* Chronic kidney disease, stage 5D (requiring continuous hemodialysis)
* Treatment with renal replacement therapy in the past 90 days
* Presence of cirrhosis (\>5 Child-Pugh score)
* Acute pulmonary embolism
* Acute myocardial infarction within 3 weeks before elective surgery
* Left ventricular ejection fraction (LVEF) less than 40% according to echocardiography
* Acute cerebrovascular accident within 3 weeks before elective surgery
* Pregnancy
* Any other clinical condition of the patient that, in the opinion of the investigator, precludes inclusion in this study
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.
What they're measuring
1
Effect of the hemoperfusion with Efferon LPS device during cardiopulmonary bypass on measures of organ dysfunction