Clinical Trial: Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

Brief Summary:

Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest shock.

The ischemic injury of the gastro-intestinal (GI) tractus is suggested by abnormalities in digestive biomarkers and by the frequent endotoxemia after CA. However, direct mucosal damage has not been clearly demonstrated after OHCA. The real incidence of ischemic lesions of GI tract and their potential involvement in the post-CA shock is therefore unknown.

We propose an original clinical research program aimed at rigorously determining the incidence of upper GI lesions after OHCA and analyzing their contribution to the severity of post-CA shock through a prospective, interventional, multicentric study


Detailed Summary:

The screening of the patients will be performed 2 to 4 days after their Intensive Care Unit (ICU) admission. Procedure and exams at the day of inclusion (day 0):

  • collection of digestive symptoms
  • carrying out the œsophago-gastro-duodenoscopy and establishment of a formal report with the eventual lesions and their ischemic nature.
  • in the absence of contra-indication and upon final decision of the gastroscopist, systematic biopsies of fundic, antral and duodenal mucosa; contra-indication of biopsies are the presence of a vascular or haemorrhagic lesion and the coagulation disorders.
  • Blood sample for H. pylori serology, and serum freezing. Urinary sample for urine freezing

Procedure and exams from day 1 to hospital discharge:

  • Daily collection of digestive symptoms and needs for vasopressor support
  • Sepsis-related Organ Failure Assessment (SOFA) score at day 2 & 5
  • Cerebral Performance Category (CPC) score determination at hospital discharge In case of digestive symptoms after day 0 and in accordance with good clinical practice, a second gastroscopy and/or an abdominal Computed Tomography scan(CT-scan) and/or a colonoscopy will be performed at the physician's discretion.

Sponsor: Versailles Hospital

Current Primary Outcome: To measure the incidence of upper digestive macroscopic lesions after out-of-hospital cardiac arrest [ Time Frame: One day ]

Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after the cardiac arrest


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Versailles Hospital

Dates:
Date Received: January 22, 2015
Date Started: November 2014
Date Completion: December 2017
Last Updated: December 13, 2015
Last Verified: December 2015