Perioperative Sepsis. An Epigenetic Perspective

NCT07442552 | Recruiting

• 1 other identifier: pese0004
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis Abdominal

Keywords

perioperative sepsis; epigenetics; echocardiography; biochemical markers in sepsis

Outcome Measures

Primary Outcomes (1)

• The impact of abdominal sepsis on the microRNA profile. Comparison of the mean values of epigenetic biomarkers across groups

  Assessment of miR-146a, miR-155, miR-223, miR-150, miR-21, miR-133a, miR-27a in plasma

  2 days before surgery until day 1 after surgery

Secondary Outcomes (10)

• The impact of abdominal sepsis on the postoperative left ventricular function. Comparison of the means of left ventricular ejection fraction (EFLV) measurements across groups.

  2 days before surgery until day 1 after surgery

• The impact of abdominal sepsis on the postoperative E/A and E/e´ ratio. Comparison of the means of the E/A and E/e´ ratios across groups.

  2 days before surgery until day 1 after surgery

• The impact of the abdominal sepsis on the postoperative velocity-time integral (VTI). Comparison of the means of the VTI across groups.

  2 days before surgery until day 1 after surgery

• The impact of abdominal sepsis on the postoperative right ventricle (RV) to right atrial (RA) gradient. Comparison of the means of the RV-to-RA gradient across groups.

  2 days before surgery until day 1 after surgery

• The impact of abdominal sepsis on the postoperative tricuspid annular plane systolic excursion (TAPSE). Comparison of the means of the TAPSE across groups.

  2 days before surgery until day 1 after surgery

Study Arms (2)

Septic

Patients with confirmed or suspected infection associated with an increase in SOFA score ≥2 points from baseline during the perioperative period.

Diagnostic Test: • Presepsin • C-reactive protein (CRP) • Fibrinogen • Aspartate aminotransferase (AST) • Alanine aminotransferase (ALT) • Creatinine • Urea • Creatine kinase (CK) • Creatine kinase-MB (CK-MB) • NT-pro

Non-septic

Patients undergoing major abdominal surgery without clinical or biological evidence of sepsis.

Diagnostic Test: • Presepsin • C-reactive protein (CRP) • Fibrinogen • Aspartate aminotransferase (AST) • Alanine aminotransferase (ALT) • Creatinine • Urea • Creatine kinase (CK) • Creatine kinase-MB (CK-MB) • NT-pro

Interventions

• Presepsin • C-reactive protein (CRP) • Fibrinogen • Aspartate aminotransferase (AST) • Alanine aminotransferase (ALT) • Creatinine • Urea • Creatine kinase (CK) • Creatine kinase-MB (CK-MB) • NT-pro DIAGNOSTIC_TEST

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

Also known as: • Transthoracic echocardiography

Non-septic; Septic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients (≥18 years) undergoing elective or emergency major abdominal surgery at a single academic university hospital. Eligible patients must be hemodynamically stable in the preoperative period, able to provide written informed consent, and have biological samples available both before surgery and within 24 hours postoperatively. A total of 40 patients are prospectively enrolled and followed during the perioperative period only. The patients are devided into septic or non-septic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

Institutul Clinic Fundeni

Bucharest, Sector 2, 022328, Romania

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Presepsine * C-reactive protein (CRP) * Fibrinogen * Aspartate aminotransferase (AST) * Alanine aminotransferase (ALT) * Creatinine * Blood ureea nitrogen * Creatine kinase (CK) * Creatine kinase-MB (CK-MB) * NT-proBNP * high sensitive troponine I (hsTnI) Molecular Analysis • Peripheral blood microRNA expression analysis (miR-146a, miR-155, miR-223, miR-150, miR-21, miR-133a, miR-27a)

MeSH Terms

Conditions

Intraabdominal Infections

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Sebastian I Isac

  Department of Anesthesia and Intensive Care I, Carol Davila University of Medicine and Pharmacy

  STUDY DIRECTOR

• Gabriela Droc, Prof.

  Department of Anesthesia and Intensive Care I, Carol Davila University of Medicine and Pharmacy

  STUDY CHAIR

Central Study Contacts

Sebastian I Isac, Assist. Prof.

CONTACT

0040744543736; sebastian.isac@umfcd.ro

Buzatu Cristina

CONTACT

0040727391477; cristina.buzatu944@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: March 2, 2026
• Study Start: January 20, 2026
• Primary Completion: March 30, 2026
• Study Completion: April 10, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

RO (1)