Perioperative Sepsis. An Epigenetic Perspective
ConditionSepsis Abdominal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCarol Davila University of Medicine and Pharmacy
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
• 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 testStudy 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Septic1 intervention
Group B: Non-septic1 intervention
Trial outcomes
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
Time frame
2 days before surgery until day 1 after surgerySecondary outcomes
1
The impact of abdominal sepsis on the postoperative left ventricular function. Comparison of the means of left ventricular ejection fraction (EFLV) measurements across groups.
Ultrasonographic assessment of the ejection fraction of the left ventricle (EFLV) in %
Time frame
2 days before surgery until day 1 after surgery2
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.
Ultrasonographic assessment of the early (E) and atrial (A) waves of the left ventricle in m/s and their ratio, and the early diastolic mitral annular velocity (e´) and E/e´ ratio respectively
Time frame
2 days before surgery until day 1 after surgery3
The impact of the abdominal sepsis on the postoperative velocity-time integral (VTI). Comparison of the means of the VTI across groups.
Ultrasonographic assessment of the velocity-time integral in cm
Time frame
2 days before surgery until day 1 after surgery4
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.
Ultrasonographic assessment of the RV to RA gradient in mmHg
Time frame
2 days before surgery until day 1 after surgerySponsors and contacts
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Source ClinicalTrials.gov