How sepsis around major abdominal surgery affects the body and genes

Impact of Perioperative Sepsis on Inflammatory, Cardiac, Coagulation, and microRNA Profiles in Patients Undergoing Major Abdominal Surgery

This project will see if changes in blood markers, heart function, and specific microRNAs before and within 24 hours after major abdominal surgery can identify adults who develop perioperative sepsis.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Carol Davila University of Medicine and Pharmacy (other)
• Locations: 1 site (Bucharest, Sector 2)
• Trial ID: NCT07442552 on ClinicalTrials.gov

What this trial studies

This is a single-center, prospective, observational cohort of 40 adult patients undergoing elective or emergency major abdominal surgery at a university hospital. Patients are classified into septic and non-septic groups using international sepsis definitions and SOFA score criteria, with no changes to standard clinical care. Clinical data, biochemical markers (including presepsin, CRP, fibrinogen, liver and kidney tests, CK/CK-MB, NT-proBNP), transthoracic echocardiography, and selected circulating microRNAs are measured preoperatively and within the first 24 hours postoperatively. The study aims to characterize pathophysiologic differences associated with perioperative sepsis and explore whether microRNA and other early markers have prognostic value for postoperative sepsis.

Who should consider this trial

Good fit: Adults (≥18 years) undergoing major abdominal surgery at the participating center who are hemodynamically stable preoperatively, can provide informed consent, and can provide blood samples before surgery and within 24 hours after surgery.

Not a fit: Patients with active chronic infections, autoimmune or systemic inflammatory diseases, chronic immunosuppression, severe hepatic failure, end-stage renal disease on dialysis, advanced heart failure, pregnancy, or inability to provide consent or required samples are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this work could enable earlier detection of postoperative sepsis using combined blood, heart, and microRNA markers, allowing faster treatment and potentially fewer complications.

How similar studies have performed: Prior studies have reported that presepsin, CRP and certain circulating microRNAs correlate with sepsis, but evidence for their early prognostic value specifically in the perioperative major abdominal surgery setting is preliminary and not yet definitive.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Bucharest, Sector 2

• Institutul Clinic Fundeni — Bucharest, Sector 2, Romania (RECRUITING)

Study contacts

• Study coordinator: Sebastian I Isac, Assist. Prof.

Conditions: Sepsis Abdominal, perioperative sepsis, epigenetics, echocardiography, biochemical markers in sepsis