Incidence, Risk Factors, and Outcomes of Gastrointestinal Complications in Patients Undergoing Heart Valve Replacement With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,444
- 试验地点
- 1
- 主要终点
- The acute gastrointestinal injury (AGI) score
研究概览
简要总结
This retrospective study investigates the relationship between cardiopulmonary bypass (CPB) duration and the incidence of gastrointestinal complications (GICs) in patients undergoing heart valve replacement. Patients will be grouped into a normal CPB group (CPB <120 minutes) and a prolonged CPB group (CPB ≥120 minutes). The study aims to determine whether prolonged CPB time is associated with a higher risk of GICs and to evaluate the outcomes and recovery process for patients who develop GICs postoperatively.
详细描述
Heart valve replacement with CPB carries a risk of GICs due to potential ischemia-reperfusion injury to the gastrointestinal tract. GICs in the postoperative period can lead to increased morbidity and prolong recovery. Prolonged CPB time may serve as a predictive factor for the development of GICs following heart valve replacement. This study will utilize established diagnostic criteria to define GICs, which include clinical symptoms, laboratory tests, and imaging as necessary, based on standards from critical care and gastrointestinal surgery guidelines. By understanding this correlation, the study aims to reduce the incidence and severity of postoperative GICs and improve surgical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing heart valve replacement with CPB
- •Age ≥ 18 years and ≤ 75 years
排除标准
- •Have received major gastrointestinal surgery within 5 years.
- •History of severe infection (e.g., pneumonia, urinary tract infection) requiring hospitalization within 1 month prior to surgery.
- •Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis.
- •Acute gastroenteritis.
- •Clostridium difficile or Helicobacter pylori infection.
- •Chronic constipation.
- •Peptic ulcer.
- •Polyps in the stomach or intestines.
- •Gastrointestinal neoplasms.
- •Abdominal hernia.
- •Irritable bowel syndrome.
- •Acute or chronic cholecystitis, hepatitis.
- •Patients who died intraoperatively or within 24 hours postoperatively.
- •Patients with digestive system tumors.
- •Pregnancy or breastfeeding could affect postoperative medication use and study observations.
- •Involvement in other studies that may interfere with the objective results of this study.
结局指标
主要结局
The acute gastrointestinal injury (AGI) score
时间窗: 1 month
The AGI score of the patient within the seventh postoperative day was performed daily according to the European Society of critical care (2012) guidelines for AGI. Determined the severity with grade 1-4,The higher the score, the more serious it is.
次要结局
- Return Time of Bowel Sounds(1 month)
- Frequency of Bowel Sounds(1 month)
- Time to First Defecation(1 month)
- Proportion of Cocci and Bacilli in Feces(1 month)
- 5.C-Reactive Protein (CRP)(1 month)
- Procalcitonin (PCT)(1 month)
- Alanine Aminotransferase (ALT)(1 month)
- Aspartate Aminotransferase (AST)(1 month)
- Creatinine(1 month)
- Left Ventricular Ejection Fraction (LVEF)(1 month)
- Ventilator assisted time (VAT)(1 month)
- Days of ICU stay(3 months)
研究者
Wenbo Meng
Director of Surgery
Hepatopancreatobiliary Surgery Institute of Gansu Province