Risk Factors of Post-ERCP Sepsis

Recruiting

• Conditions: Bacteremia Sepsis; Sepsis; Intraoperative 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.

Study Timeline

• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2023-12-17
• Study Start: 2023-12-23
• Status Verified: 2024-01
• Study First Posted: 2024-01-02
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Undergoing ERCP for obstructive jaundice
• Adult (Older than 18 years old)
• Written Informed Consent

Exclusion Criteria

• 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)

Trial Locations

Locations (1)

Mansoura Univesity Faculty of Medicine; 🇪🇬 Mansoura, Aldakahlia, Egypt