Bacteremia Sepsis, Intraoperative Hypotension, Sepsis
Conditions
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.
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.
Interventions
PROCEDUREexposure 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.
Sponsors
Mansoura University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-ERCP Sepsis | 24 hours after ERCP | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-ERCP ICU admission | 7 days after ERCP | post-ERCP admission to the ICU for any cause (dicotomus outcome: yes or no) |
| Length of hospital stay | 30 days after ERCP | in days (continuous outcome) |
| Postoperative bacteremia | 24 hours after surgery | Bactermia on blood culture (post-ERCP in comparison to the pre-ERCP blood culture): (dicotomus outcome: yes or no) |
| Hospital readmission | 30 days after ERCP | Hospital readmission (dicotomus outcome: yes or no) |
| Post-ERCP RBCs transfusion | 24 hours after ERCP | any amount of red blood tranfusion after the ERCP (dicotomus outcome: yes or no) |
| 30-day all-cause mortality | 30 days after ERCP | Death of any cause (dicotomus outcome: yes or no) |
| Delayed post-ERCP Sepsis | 7 days after ERCP procedure | SOFA score ≥ 2 or increase in the SOFA score by ≥ 2 from the baseline (dicotomus outcome: yes or no) |
| Post-ERCP pancreatitis | 24 hours after ERCP | Raised lipases and amylase (dicotomus outcome: yes or no) |
Countries
Egypt
Contacts
Primary ContactMoataz M Emara, MD, EDAIC
Backup ContactAhmed Ali El-Din, Msc
Outcome results
None listed