Risk Factors of Post-ERCP Sepsis

NCT06187168 | Unknown DMC

• 1 other identifier: R.23.11.2387
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Intraoperative Hypotension; Bacteremia Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Hospital readmission

  30 days after ERCP

• Post-ERCP ICU admission

  7 days after ERCP

• Length of hospital stay

  30 days after ERCP

• Postoperative bacteremia

  24 hours after surgery

• Post-ERCP pancreatitis

  24 hours after ERCP

Study Arms (2)

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.

No intraoperative hypotension

Not meeting the above definition of hypotension per our protocol (by timing, threshold, and method).

Interventions

exposure to hypotension during the Endoscopic Retrograde Cholangiopancreatography (ERCP) for obstructive jundice. PROCEDURE

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.

intraoperative hypotension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Already on sepsis before the ERCP
• Pregnancy

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Univesity Faculty of Medicine

Al Mansurah, Aldakahlia, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Moataz M Emara, MD, EDAIC

  Mansoura University Hospital

  STUDY CHAIR

Central Study Contacts

Moataz M Emara, MD, EDAIC

CONTACT

+201064048848; mm.emara@mans.edu.eg

Ahmed Ali El-Din, Msc

CONTACT

0201288045390

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 2, 2024
• Study Start: December 23, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: within 2 years after publication
• Access Criteria: with contact with the principal investigator with reasonable request and approval of the local IRB.

Locations

EG (1)