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Hemoperfusion Efferon LPS During Cardiac Surgery Using Cardiopulmonary Bypass

NCT06659289 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-12-09

No results posted yet for this study

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.

Conditions

  • Cardiac Disease
  • Multiple Organ Dysfunction Syndrome

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. The hemoperfusion procedure is performed at the time of cardiopulmonary bypass during cardiac surgery. The therapy (Efferon LPS hemoperfusion) is performed once. The duration of the procedure is limited by the time ofcardiopulmonary bypass.

Sponsors & Collaborators

  • Efferon JSC

    lead INDUSTRY

Principal Investigators

  • Yuri Polushin, PhD,MD · Pavlov First Saint Petersburg State Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2025-04-22
Completion
2025-05-06

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06659289 on ClinicalTrials.gov