NCT07442552 Perioperative Sepsis. An Epigenetic Perspective
| NCT ID | NCT07442552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carol Davila University of Medicine and Pharmacy |
| Condition | Sepsis Abdominal |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2026-01-20 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Sebastian I Isac
STUDY DIRECTOR
Department of Anesthesia and Intensive Care I, Carol Davila University of Medicine and Pharmacy
Frequently Asked Questions
Who can join the NCT07442552 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis Abdominal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07442552 currently recruiting?
Yes, NCT07442552 is actively recruiting participants. Contact the research team at sebastian.isac@umfcd.ro for enrollment information.
Where is the NCT07442552 trial being conducted?
This trial is being conducted at Bucharest, Romania.
Who is sponsoring the NCT07442552 clinical trial?
NCT07442552 is sponsored by Carol Davila University of Medicine and Pharmacy. The principal investigator is Sebastian I Isac at Department of Anesthesia and Intensive Care I, Carol Davila University of Medicine and Pharmacy. The trial plans to enroll 40 participants.