Perioperative Sepsis. An Epigenetic Perspective
Impact of Perioperative Sepsis on Inflammatory, Cardiac, Coagulation, and microRNA Profiles in Patients Undergoing Major Abdominal Surgery
Carol Davila University of Medicine and Pharmacy
40 participants
Jan 20, 2026
OBSERVATIONAL
Conditions
Summary
This single-center, prospective, observational study evaluates the impact of perioperative sepsis on inflammatory response, coagulation abnormalities, cardiac dysfunction, and microRNA expression in adult patients undergoing major abdominal surgery. Forty patients are enrolled and classified into septic and non-septic groups according to international sepsis definitions based on SOFA score criteria. Clinical, biochemical, echocardiographic, and molecular parameters, including selected microRNAs, are assessed preoperatively and within the first 24 hours postoperatively. The study aims to characterize pathophysiological differences associated with perioperative sepsis and to explore the potential prognostic value of microRNAs as early biomarkers of postoperative sepsis.
Eligibility
Inclusion Criteria5
- Age ≥18 years
- Undergoing major abdominal surgery (elective or emergency)
- Ability to provide written informed consent
- Availability of biological samples in the preoperative period and within 24 hours postoperatively
- Preoperative hemodynamic stability
Exclusion Criteria10
- Surgical reintervention within 3 months after the index procedure
- Multiple surgical procedures during the same hospitalization
- Active chronic infections (HIV, active viral hepatitis, tuberculosis)
- Autoimmune or systemic inflammatory diseases
- Chronic immunosuppressive therapy or long-term corticosteroid use
- Severe hepatic failure (Child-Pugh class C)
- End-stage renal disease requiring dialysis
- Severe pre-existing cardiac disease (NYHA class III-IV heart failure)
- Pregnancy
- Refusal or inability to provide informed consent
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Interventions
Study procedures are limited to the collection of clinical data, transthoracic echocardiography, and peripheral blood samples obtained preoperatively and within 24 hours postoperatively. Laboratory analyses include inflammatory markers (presepsin, C-reactive protein), coagulation parameters (fibrinogen), biochemical and organ function markers (AST, ALT, creatinine, urea), cardiac injury and function markers (creatine kinase, CK-MB, NT-proBNP, cardiac troponin), and peripheral blood microRNA expression (miR-146a, miR-155, miR-223, miR-150, miR-21, miR-133a, miR-27a). Patient classification into septic or non-septic cohorts is based solely on postoperative clinical assessment and SOFA score
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07442552