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.
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
100
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.
Mansoura Univesity Faculty of Medicine
Al Mansurah, Aldakahlia, Egypt
RECRUITINGPost-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)
Time frame: 24 hours after ERCP
Hospital readmission
Hospital readmission (dicotomus outcome: yes or no)
Time frame: 30 days after ERCP
Post-ERCP ICU admission
post-ERCP admission to the ICU for any cause (dicotomus outcome: yes or no)
Time frame: 7 days after ERCP
Length of hospital stay
in days (continuous outcome)
Time frame: 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)
Time frame: 24 hours after surgery
Post-ERCP pancreatitis
Raised lipases and amylase (dicotomus outcome: yes or no)
Time frame: 24 hours after ERCP
Post-ERCP RBCs transfusion
any amount of red blood tranfusion after the ERCP (dicotomus outcome: yes or no)
Time frame: 24 hours after ERCP
30-day all-cause mortality
Death of any cause (dicotomus outcome: yes or no)
Time frame: 30 days after ERCP
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Delayed post-ERCP Sepsis
SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline (dicotomus outcome: yes or no)
Time frame: 7 days after ERCP procedure