Risk Factors of Post-ERCP Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-23

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sepsis Intraoperative Hypotension Bacteremia Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type 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.

No intraoperative hypotension

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

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE