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Recruiting NCT07532174

Efferon LPS Hemoadsorption in Cardiac Surgery Patients

No phase Interventional Cardiac Disease Multiple Organ Dysfunction Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Efferon LPS.
Who it may be relevant to
Registry conditions: Cardiac Disease, Multiple Organ Dysfunction Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Intraoperative and Early Postoperative Use of Lipopolysaccharide Adsorption (Efferon LPS) in Cardiac Surgery Patients to Reduce the Incidence of Multiple Organ Dysfunction Syndrome in the Postoperative Period

Overview

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.

Detailed description

Annually, over 1 million people worldwide undergo cardiac surgery. Most cardiac procedures still require cardiopulmonary bypass (CPB), myocardial protection during aortic cross-clamping, and the induction of cardioplegic arrest by administering cardioplegic solutions into the coronary circulation. All of these factors contribute to ischemia-reperfusion injury of the myocardium, which remains a leading cause of acute heart failure following the restoration of spontaneous circulation and, consequently, the development of post-perfusion multiple organ dysfunction, particularly acute kidney injury (AKI).

AKI occurs in approximately 7% of all hospitalized patients, 30% of intensive care unit patients, and up to 30% of patients undergoing cardiac surgery. Endotoxemia is one of the major contributors to the development of AKI. Septic AKI, compared with non-septic AKI, is associated with poorer prognosis, longer hospital stays, and lower survival rates.

The goal of the study is to evaluate the safety and efficacy 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.

Interventions

  • Device Efferon LPS
    Efferon 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.

Primary outcome measures

  • SOFA [Time frame: 1-7 days]
Secondary outcome measures (6)
  • Vasopressor free days [Time frame: 1-28 days]
  • Renal replacement therapy (RRT) duration [Time frame: 1-28 days]
  • Mechanical ventilation duration [Time frame: 1-28 days]
  • Length of stay in the intensive care unit [Time frame: 1-28 days]
  • 28 days mortality [Time frame: 1-28 days]
  • Incidence of postoperative complications [Time frame: 1-28 days]

Eligibility criteria

Inclusion criteria

  • Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB).
  • EuroSCORE II ≥6%

Exclusion criteria

  • 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
  • Any other clinical condition that, in the investigator's opinion, would preclude the patient's participation in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 3 centers
  • Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary" — Barnaul
  • Almazov National Medical Research Centre — Saint Petersburg
  • Pavlov First Saint Petersburg State Medical University — Saint Petersburg

Identifiers

NCT: NCT07532174 · efferon-lps-2024-04.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗