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临床试验/NCT05498935
NCT05498935已完成不适用

Prolonged Cardiopulmonary Bypass (CPB) Time as a Predictive Factor for Acute Gastrointestinal Injury (AGI) After Heart Valve Replacement

Hepatopancreatobiliary Surgery Institute of Gansu Province1 个研究点 分布在 1 个国家目标入组 1,070 人开始时间: 2022年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,070
试验地点
1
主要终点
Cardiopulmonary bypass (CPB) time

研究概览

简要总结

In this retrospective study, the investigators will analyze the correlation between cardiopulmonary bypass (CPB) time and acute gastrointestinal injury (AGI), and the outcomes of AGI in patients undergoing heart valve replacement.

详细描述

Patients with heart valve diseases often have chronic cardiac insufficiency. Patients undergoing heart valve replacement with CPB are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI after cardiovascular surgery, especially in that use CPB, is associated with significant morbidity and an increase in peri-operative mortality. Prolonged CPB time could be predictive of AGI following heart valve replacement. This study is to analyze the correlation between CPB time and AGI, and the outcomes of AGI in patients undergoing heart valve replacement. The investigators hope that the benefits will include fewer patients becoming seriously postoperative AGI and mortality after cardiac surgery.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing heart valve replacement surgery with CPB
  • Age > 18 years and ≤ 70 years

排除标准

  • Patients combined with severe hematological disease, respiratory disease, and other critical diseases
  • Patients had severe disorder of multiple systems and organs or severe pulmonary hypertension
  • Have received major gastrointestinal surgery within 5 years
  • 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 during surgery
  • Patients with digestive system tumors

结局指标

主要结局

Cardiopulmonary bypass (CPB) time

时间窗: 1 month

Was defined it as the sum of times of CPB during surgery (minutes).

The AGI score

时间窗: 1 month

The AGI score of the patient within the seventh postoperative day was performed according to the European Society of critical care (2012) guidelines for AGI.

次要结局

  • Number of bowel sounds(1 month)
  • Proportion of cocci and bacilli in feces(1 month)
  • First defecation time(1 month)
  • Alanine aminotransferase (ALT)(1 month)
  • Aspartate aminotransferase (AST)(1 month)
  • Left ventricular ejection fraction (LVEF)(1 month)

研究者

发起方
Hepatopancreatobiliary Surgery Institute of Gansu Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenbo Meng

Professor of Surgery

Hepatopancreatobiliary Surgery Institute of Gansu Province

研究点 (1)

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