Risk Factors of Post-ERCP Sepsis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Intraoperative Hypotension; Bacteremia Sepsis
• Intervention / Treatment: Procedure: exposure to hypotension during the Endoscopic Retrograde Cholangiopancreatography (ERCP) for obstructive jundice.

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Moataz M Emara, Md, EDAIC; Phone Number: +201064048848; Email: mm.emara@mans.edu.eg
• Study Contact Backup: Name: Ahmed Ali El-Din, Msc; Phone Number: 0201288045390

Study Locations

• Egypt
  • Aldakahlia
    • Mansoura, Aldakahlia, Egypt, 35516
      • Recruiting
      • Mansoura Univesity Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study population will include 100 adult patients (≥ 18years) undergoing ERCP for obstructive jaundice at the GISC during the study period for obstructive jaundice.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
intraoperative hypotension; 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.	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.
No intraoperative hypotension; Not meeting the above definition of hypotension per our protocol (by timing, threshold, and method).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital readmission	Hospital readmission (dicotomus outcome: yes or no)	30 days after ERCP
Post-ERCP ICU admission	post-ERCP admission to the ICU for any cause (dicotomus outcome: yes or no)	7 days after ERCP
Length of hospital stay	in days (continuous outcome)	30 days after ERCP
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
Post-ERCP pancreatitis	Raised lipases and amylase (dicotomus outcome: yes or no)	24 hours after ERCP
Post-ERCP RBCs transfusion	any amount of red blood tranfusion after the ERCP (dicotomus outcome: yes or no)	24 hours after ERCP
30-day all-cause mortality	Death of any cause (dicotomus outcome: yes or no)	30 days after ERCP
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Moataz M Emara, MD, EDAIC, Mansoura University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Toxemia; Bacteremia; Hypotension
• Other Study ID Numbers: R.23.11.2387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The anonymized patient data will be available with the principal investigator and can be shared on reasonable request after approval of the IRB.
• IPD Sharing Time Frame: within 2 years after publication
• IPD Sharing Access Criteria: with contact with the principal investigator with reasonable request and approval of the local IRB.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No