Actively Recruiting
Efferon LPS Hemoadsorption in Cardiac Surgery Patients
Led by Efferon JSC · Updated on 2026-04-15
60
Participants Needed
3
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized controlled study aims to evaluate the efficacy and safety of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass in reducing the incidence and severity of multiple organ dysfunction syndrome (MODS) in the postoperative period. Each patient in the treatment group will undergo two hemoadsorption sessions: first during cardiopulmonary bypass (CPB) at the time of cardiac surgery, with the duration determined by the CPB time, and second within 24 hours postoperatively, for a minimum duration of 6 hours.
CONDITIONS
Official Title
Efferon LPS Hemoadsorption in Cardiac Surgery Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB).
- EuroSCORE II 6%
You will not qualify if you...
- Procalcitonin 62 ng/mL
- Severe chronic liver disease, defined as Child-Pugh class C (>10 points) or clinically manifest hepatic failure
- Dialysis-dependent chronic kidney disease (CKD)
- Ongoing immunosuppressive therapy, including corticosteroids or cytotoxic agents, excluding standard perioperative medications
- Any other clinical condition that, in the investigator's opinion, would preclude the patient's participation in the study
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary"
Barnaul, Russia
Actively Recruiting
2
Almazov National Medical Research Centre
Saint Petersburg, Russia
Actively Recruiting
3
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Russia
Actively Recruiting
Research Team
A
Alexandr Shelehov-Kravchenko, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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