An observational study in Sepsis Abdominal, sponsored by Carol Davila University of Medicine and Pharmacy. Recruiting at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Carol Davila University of Medicine and Pharmacy · Observational
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.
This study is a single-center, prospective, observational cohort study designed to investigate the pathophysiological impact of perioperative sepsis on inflammatory, cardiac, coagulation, and microRNA profiles in adult patients undergoing major abdominal surgery. The study is conducted at a university hospital within the Department of Intensive Care and is strictly observational, with no modification to standard perioperative clinical management.
Major abdominal surgery is associated with a significant inflammatory response and carries a substantial risk of postoperative complications, including sepsis. Perioperative sepsis is known to contribute to organ dysfunction, particularly affecting the cardiovascular and coagulation systems; however, the underlying biological and molecular mechanisms remain incompletely understood. In particular, the role of circulating microRNAs as early biomarkers and potential mediators of sepsis-related organ dysfunction in the perioperative setting has not been fully elucidated. This study aims to characterize the early biological, echocardiographic, and molecular changes associated with perioperative sepsis.
A total of 40 adult patients (≥18 years) undergoing elective or emergency major abdominal surgery are enrolled after providing written informed consent. All participants must be hemodynamically stable preoperatively and have available biological samples obtained in the preoperative period and within the first 24 hours after surgery. Patients are followed during the perioperative period only, with no long-term follow-up beyond 24 hours postoperatively.
Following surgery, patients are classified into two cohorts based on international sepsis definitions and Sequential Organ Failure Assessment (SOFA) score criteria. The septic cohort consists of patients with confirmed or suspected infection associated with an increase in SOFA score of at least 2 points from baseline. The non-septic cohort includes patients undergoing major abdominal surgery without clinical, biological, or organ dysfunction evidence of sepsis. Allocation to study groups is non-randomized and determined solely by sepsis criteria.
Biological assessments are performed preoperatively and within 24 hours postoperatively and include markers of systemic inflammation, coagulation, organ function, and cardiac injury. These include presepsine, C-reactive protein, fibrinogen, liver enzymes (AST, ALT), renal function markers (creatinine, urea), creatine kinase and CK-MB, NT-proBNP, and cardiac troponin. Cardiac function is further evaluated using transthoracic echocardiography to assess sepsis-related myocardial dysfunction.
In parallel, peripheral blood samples are collected for molecular analysis of selected microRNAs implicated in inflammation, immune regulation, coagulation, and cardiac injury. The microRNAs analyzed include miR-146a, miR-155, miR-223, miR-150, miR-21, miR-133a, and miR-27a. MicroRNA expression levels are evaluated preoperatively and within the first 24 hours after surgery.
The primary objective is to assess the impact of perioperative sepsis on inflammatory, cardiac, coagulation, and microRNA profiles. Secondary objectives include comparisons of these biomarkers between septic and non-septic patients, correlations between SOFA score and biological, echocardiographic, and molecular parameters, and exploration of associations between microRNA expression patterns and the severity of organ dysfunction. An additional exploratory objective is to evaluate the potential prognostic value of selected microRNAs as early biomarkers of postoperative sepsis.
The study is conducted in accordance with the Declaration of Helsinki and applicable national regulations. No study-related interventions are performed, and all data collection is based on routine clinical assessments and additional laboratory analyses performed on collected samples.
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.
Exclusion Criteria:
Patients with confirmed or suspected infection associated with an increase in SOFA score ≥2 points from baseline during the perioperative period.
Diagnostic Test: • Presepsin • C-reactive protein (CRP) • Fibrinogen • Aspartate aminotransferase (AST) • Alanine aminotransferase (ALT) • Creatinine • Urea • Creatine kinase (CK) • Creatine kinase-MB (CK-MB) • NT-pro
Patients undergoing major abdominal surgery without clinical or biological evidence of sepsis.
Diagnostic Test: • Presepsin • C-reactive protein (CRP) • Fibrinogen • Aspartate aminotransferase (AST) • Alanine aminotransferase (ALT) • Creatinine • Urea • Creatine kinase (CK) • Creatine kinase-MB (CK-MB) • NT-pro
Study 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
Also known as: • Transthoracic echocardiography
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 surgery
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 surgery
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 surgery
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 surgery
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 surgery
The impact of abdominal sepsis on the postoperative tricuspid annular plane systolic excursion (TAPSE). Comparison of the means of the TAPSE across groups.
Ultrasonographic assessment of the tricuspid annular plane systolic excursion (TAPSE) in mm.
Time frame: 2 days before surgery until day 1 after surgery
The impact of abdominal sepsis on the postoperative diameter of the inferior vena cava (IVC). Comparison of the means of IVC diameter across groups.
Ultrasonographic assessment of the IVC diameter in mm.
Time frame: 2 days before surgery until day 1 after surgery
The impact of abdominal sepsis on the postoperative systolic tissue velocity (s´) wave of the right ventricular free wall. Comparison of the means of the s´ wave across groups.
Ultrasonographic assessment of the s´ wave of the right ventricle free wall in cm/s.
Time frame: 2 days before surgery until day 1 after surgery
The impact of abdominal sepsis on the postoperative dynamics of cardiac biomarkers and presepsine. Comparison of the means of cardiac biomarkers and presepsine across groups.
Assessment of cardiac biomarkers in plasma, such as highly sensitive troponine I (hsTnI) (pg/ml), NT-proBNP (pg/ml), procalcitonine (PCT) (pg/ml), and presepsine (pg/ml)- as a biomarker for sepsis
Time frame: 2 days before surgery until day 1 after surgery
The impact of abdominal sepsis on liver function. Comparison of the means of liver enzymes across groups.
Assessment of the aspartate aminotransferase (AST) (U/L), and alanine aminotransferase (ALT) (U/L),
Time frame: 2 days before surgery until day 1 after surgery
The impact of abdominal sepsis on the postoperative inflammation and renal function. Comparison of the means of the biomarkers for inflammation and renal function across groups.
Assessment of the following markers in plasma: C-reactive protein (CRP) (mg/dl), Fibrinogen (mg/dl), Creatinine (mg/dl), blood urea nitrogen (BUN) (mg/dl)
Time frame: 2 days before surgery and day 1 after surgery
Plan to share: Undecided — due confidential data sharing and explicit consent
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Carol Davila University of Medicine and Pharmacy