Risk Factors of Post-ERCP Sepsis
- Conditions
- Bacteremia SepsisSepsisIntraoperative Hypotension
- Registration Number
- NCT06187168
- Lead Sponsor
- Mansoura University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Undergoing ERCP for obstructive jaundice
- Adult (Older than 18 years old)
- Written Informed Consent
- Already on sepsis before the ERCP
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post-ERCP Sepsis 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)
- Secondary Outcome Measures
Name Time Method Post-ERCP pancreatitis 24 hours after ERCP Raised lipases and amylase (dicotomus outcome: yes or no)
Hospital readmission 30 days after ERCP Hospital readmission (dicotomus outcome: yes or no)
Post-ERCP ICU admission 7 days after ERCP post-ERCP admission to the ICU for any cause (dicotomus outcome: yes or no)
Length of hospital stay 30 days after ERCP in days (continuous outcome)
30-day all-cause mortality 30 days after ERCP Death of any cause (dicotomus outcome: yes or no)
Postoperative bacteremia 24 hours after surgery Bactermia on blood culture (post-ERCP in comparison to the pre-ERCP blood culture): (dicotomus outcome: yes or no)
Post-ERCP RBCs transfusion 24 hours after ERCP any amount of red blood tranfusion after the ERCP (dicotomus outcome: yes or no)
Delayed post-ERCP Sepsis 7 days after ERCP procedure SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline (dicotomus outcome: yes or no)
Related Research Topics
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Trial Locations
- Locations (1)
Mansoura Univesity Faculty of Medicine
🇪🇬Mansoura, Aldakahlia, Egypt
Mansoura Univesity Faculty of Medicine🇪🇬Mansoura, Aldakahlia, Egypt