Impact of Perioperative Sepsis on Inflammatory, Cardiac, Coagulation, and microRNA Profiles in Patients Undergoing Major Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The impact of abdominal sepsis on the microRNA profile. Comparison of the mean values of epigenetic biomarkers across groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Septic
Patients with confirmed or suspected infection associated with an increase in SOFA score ≥2 points from baseline during the perioperative period.
干预措施: • 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 Test)
Non-septic
Patients undergoing major abdominal surgery without clinical or biological evidence of sepsis.
干预措施: • 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 Test)
结局指标
主要结局
The impact of abdominal sepsis on the microRNA profile. Comparison of the mean values of epigenetic biomarkers across groups
时间窗: 2 days before surgery until day 1 after surgery
Assessment of miR-146a, miR-155, miR-223, miR-150, miR-21, miR-133a, miR-27a in plasma
次要结局
- The impact of abdominal sepsis on the postoperative left ventricular function. Comparison of the means of left ventricular ejection fraction (EFLV) measurements across groups.(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.(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.(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.(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.(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.(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.(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.(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.(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.(2 days before surgery and day 1 after surgery)
研究者
Sebastian Isac
Assist. Prof.
Carol Davila University of Medicine and Pharmacy