Intra-operative Hypotension and Sepsis After Endoscopic Retrograde Cholangiopancreatography: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post-ERCP Sepsis
研究概览
简要总结
For the treatment of numerous biliary and pancreatic problems, the procedure known as endoscopic retrograde cholangiopancreatography (ERCP) is regarded as a crucial therapeutic intervention. However, ERCP is known to be connected to a variety of issues, including post-ERCP sepsis. This study's goal is to investigate the relationship between unexplained hypotension during or just after surgery and the emergence of sepsis after ERCP.
详细描述
At the Gastrointestinal Surgery Centre, Mansura University, Egypt, a cohort study will be conducted on a sample of 50 adult (18+) patients who undergoing ERCP. Hypotension that occurred during surgery or shortly after will be classified as exposure when it cannot be linked to a particular cause. In this study, post-ERCP sepsis will be the major outcome measure, while other ERCP-related sequelae will be the supplementary outcome measures.
Discussion:
The findings of this study will significantly advance our understanding of the potential link between intraoperative hypotension and the development of post-ERCP sepsis. This study's goal is to increase knowledge of the challenges presented by ERCP, which will aid in the creation of patient treatment methods that are more effective.
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
- •Undergoing ERCP for obstructive jaundice
- •Adult (Older than 18 years old)
- •Written Informed Consent
排除标准
- •Already on sepsis before the ERCP
- •Pregnancy
结局指标
主要结局
Post-ERCP Sepsis
时间窗: 24 hours after ERCP
Definition: SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline (dicotomus outcome: yes or no)
次要结局
- Post-ERCP pancreatitis(24 hours after ERCP)
- Hospital readmission(30 days after ERCP)
- Post-ERCP ICU admission(7 days after ERCP)
- Length of hospital stay(30 days after ERCP)
- 30-day all-cause mortality(30 days after ERCP)
- Delayed post-ERCP Sepsis(7 days after ERCP procedure)
- Postoperative bacteremia(24 hours after surgery)
- Post-ERCP RBCs transfusion(24 hours after ERCP)