Risk Factors of Post-ERCP Sepsis

Sepsis Clinical Trial

Official title:

Intra-operative Hypotension and Sepsis After Endoscopic Retrograde Cholangiopancreatography: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187168
• Other study ID #: R.23.11.2387
• Status: Recruiting
• Start date: December 23, 2023
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Mansoura University
• Contact: Moataz M Emara, MD, EDAIC
• Phone: +201064048848
• Email: mm.emara[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Bacteremia Sepsis
• Hypotension
• Intraoperative Hypotension
• Sepsis
• Toxemia

Intervention

Procedure:
• exposure to hypotension during the Endoscopic Retrograde Cholangiopancreatography (ERCP) for obstructive jundice.
This is not an intended intervention in the study. This cohort study will study the exposure to intraoperative hypotension and the occurrence of sepsis after the ERCP procedures.

Locations

Country	Name	City	State
Egypt	Mansoura Univesity Faculty of Medicine	Mansoura	Aldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ERCP Sepsis	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)	24 hours after ERCP
Secondary	Hospital readmission	Hospital readmission (dicotomus outcome: yes or no)	30 days after ERCP
Secondary	Post-ERCP ICU admission	post-ERCP admission to the ICU for any cause (dicotomus outcome: yes or no)	7 days after ERCP
Secondary	Length of hospital stay	in days (continuous outcome)	30 days after ERCP
Secondary	Postoperative bacteremia	Bactermia on blood culture (post-ERCP in comparison to the pre-ERCP blood culture): (dicotomus outcome: yes or no)	24 hours after surgery
Secondary	Post-ERCP pancreatitis	Raised lipases and amylase (dicotomus outcome: yes or no)	24 hours after ERCP
Secondary	Post-ERCP RBCs transfusion	any amount of red blood tranfusion after the ERCP (dicotomus outcome: yes or no)	24 hours after ERCP
Secondary	30-day all-cause mortality	Death of any cause (dicotomus outcome: yes or no)	30 days after ERCP
Secondary	Delayed post-ERCP Sepsis	SOFA score = 2 or increase in the SOFA score by = 2 from the baseline (dicotomus outcome: yes or no)	7 days after ERCP procedure