NCT02349074: ENTRACT

Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

Completed NA Last updated 27 May 2022

What this trial tests

NA trial testing Digestive endoscopy in Out-of-hospital Cardiac Arrest in 221 participants. Completed in 1 September 2019.

Timeline

12 November 2014

Primary endpoint
30 November 2018

1 September 2019

Quick facts

Lead sponsor	Versailles Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	221
Start date	12 November 2014
Primary completion	30 November 2018
Estimated completion	1 September 2019
Sites	9 locations across Belgium, France

Drugs / interventions tested

• Digestive endoscopy

Conditions studied

• Out-of-hospital Cardiac Arrest — all drugs for Out-of-hospital Cardiac Arrest →

Sponsor

Versailles Hospital

Who can join

18 and older, any sex, with Out-of-hospital Cardiac Arrest. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Post-resuscitation shock: recent advances in pathophysiology and treatment.
   Jozwiak M, Bougouin W, Geri G, Grimaldi D, et al · · 2020 · cited 83× · PMID 33315152 · DOI 10.1186/s13613-020-00788-z
2. Ischemic injury of the upper gastrointestinal tract after out-of-hospital cardiac arrest: a prospective, multicenter study.
   Grimaldi D, Legriel S, Pichon N, Colardelle P, et al · · 2022 · cited 15× · PMID 35287719 · DOI 10.1186/s13054-022-03939-9