Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

Status Completed

Clinical Trial 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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02349074
Study type	Interventional
Source	Versailles Hospital
Contact
Status	Completed
Phase	N/A
Start date	November 12, 2014
Completion date	September 1, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT — ENTRACT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms