Efficacy and Safety of Lipopolysaccharide Adsorption (Efferon LPS) During Cardiac Surgery Using Cardiopulmonary Bypass to Reduce the Incidence of Multiple Organ Dysfunction Syndrome in the Postoperative Period

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Planned cardiac surgery (aortocoronary bypass, heart valve replacement, etc.) requiring the use of cardiopulmonary bypass

Locations
Other Locations
Russian Federation
Pavlov First Saint Petersburg State Medical University
RECRUITING
Saint Petersburg
Contact Information
Primary
Alexandr Shelehov-Kravchenko, PhD, MD
ais@efferon.ru
+79636564765
Time Frame
Start Date: 2024-11-11
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 60
Treatments
No_intervention: Baseline therapy
Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass without hemoperfusion.
Experimental: Basic therapy + Efferon LPS
Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass and will receive hemoperfusion with Efferon LPS.
Related Therapeutic Areas
Sponsors
Leads: Efferon JSC

This content was sourced from clinicaltrials.gov

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