Risk Factors of Post-ERCP Sepsis
- Conditions
- Bacteremia SepsisSepsisIntraoperative Hypotension
- Interventions
- Procedure: exposure to hypotension during the Endoscopic Retrograde Cholangiopancreatography (ERCP) for obstructive jundice.
- 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
- Arm && Interventions
Group Intervention Description intraoperative hypotension exposure to hypotension during the Endoscopic Retrograde Cholangiopancreatography (ERCP) for obstructive jundice. The exposure is intra-operative hypotension during the ERCP procedure (hypotension is defined as a 20% reduction in the mean arterial blood pressure (MAP) or systolic arterial blood pressure (SAP) \< 90 mmHg during CBD manipulation or after obstruction relief). The basal blood pressure (BP) will be the immediate reading before the endoscope insertion while the patient is in his left lateral position.
- 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)
Trial Locations
- Locations (1)
Mansoura Univesity Faculty of Medicine
🇪🇬Mansoura, Aldakahlia, Egypt