Efferon LPS Hemoadsorption in Cardiac Surgery Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEfferon JSC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB).
EuroSCORE II ≥6%
Disqualifiers
Procalcitonin ≥2 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
Trial design
Design model
Parallel
Treatments tested in this trial
Efferon LPS
DeviceEfferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. Efferon LPS hemoadsorption will be performed twice: 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Baseline therapyNo intervention 0 interventions
Group B: Basic therapy + Efferon LPSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
SOFA
The Sequential Organ Failure Assessment (SOFA) score is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall score, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA score, the less pronounced organ failure and the better the patient's survival prognosis.
Time frame
1-7 daysSecondary outcomes
1
Vasopressor free days
* Vasopressor free days = 0 if subject dies within 28 days of starting vasopressor support. * Vasopressor free days = 28 - x if vasopressor support is successfully discontinued x days after initiation. * Vasopressor free days = 0 if the subject requires vasopressor support for more than 28 days.
Time frame
1-28 days2
Renal replacement therapy (RRT) duration
* RRT-free days = 0 if the subject dies within 28 days of starting renal replacement therapy. * RRT-free days = 28 - x if RRT is successfully discontinued x days after initiation. * RRT-free days = 0 if the subject requires RRT for more than 28 days.
Time frame
1-28 days3
Mechanical ventilation duration
Ventilator-free days = 0 if subject dies within 28 days of mechanical ventilation. Ventilator-free days = 28 - x if successfully liberated from ventilation x days after initiation. Ventilator-free days = 0 if the subject is mechanically ventilated for \>28 days.
Time frame
1-28 days4
Length of stay in the intensive care unit
Time (number of days) from surgery to transfer from the intensive care unit within 60 days
Time frame
1-28 daysSponsors and contacts
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Source ClinicalTrials.gov