Perioperative Sepsis. An Epigenetic Perspective (NCT07442552) | Clinical Trial Compass
RecruitingNot Applicable
Perioperative Sepsis. An Epigenetic Perspective
Romania40 participantsStarted 2026-01-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The impact of abdominal sepsis on the microRNA profile. Comparison of the mean values of epigenetic biomarkers across groups
Timeframe: 2 days before surgery until day 1 after surgery
Trial details
NCT IDNCT07442552
SponsorCarol Davila University of Medicine and Pharmacy