How sepsis around major abdominal surgery affects the body and genes
Official title: Impact of Perioperative Sepsis on Inflammatory, Cardiac, Coagulation, and microRNA Profiles in Patients Undergoing Major Abdominal Surgery
Run by Carol Davila University of Medicine and Pharmacy · NCT07442552 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Carol Davila University of Medicine and Pharmacy Academic / other |
| Locations | 1 site (Bucharest, Sector 2) |
| Status | Recruiting |
| Started | January 20, 2026 |
| Main results expected | March 30, 2026 |
| Study ends | April 10, 2026 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT07442552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Institutul Clinic Fundeni
Bucharest, Sector 2, Romania Recruiting
Study contacts
- Study coordinator: Sebastian I Isac, Assist. Prof.
- Email: sebastian.isac@umfcd.ro
- Phone: 0040744543736
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.