Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT (ENTRACT)

May 23, 2022 updated by: Dr David GRIMALDI, Versailles Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Hospital Erasme
  • France
      • Cherbourg-Octeville, France, 50102
        • Cotentin Hospital, Medical intensive care unit
      • Colombes, France
        • Hospital Louis MOURIER
      • Corbeil-Essonnes, France, 91100
        • Sud Francilien Hospital, Medicla care unit
      • Créteil, France, 94010
        • Henri Mondor Hospital, Medical Intensive care unit
      • Limoges, France, 87042
        • Dupuytren hospital, Medical intensive care unit
      • Orléans, France, 45067
        • Orléans Hospital, Medical intensive care unit
      • Paris, France, 75014
        • Cochin Hospital, Médical intensive care unit
    • Les Yvelines
      • Le chesnay, Les Yvelines, France, 78150
        • André Mignot Hospital, Intensive care unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patient hospitalized for less than 5 days in a participating Intensive Unit Care following successfully resuscitated out-of-hospital cardiac arrest
  • Patient still mechanically ventilated
  • Hypothermia period over, corporal temperature > 36°C.
  • Written consent from a next of kin

Exclusion Criteria:

  • In-hospital cardiac arrest
  • Patients extubated before gastroscopy
  • Contra-indication of gastroscopy: suspicion of digestive perforation, severe bleeding diathesis despite coagulation products transfusion, or suspicion of Creutzfeldt-jacob disease
  • Patients with cardiac valvular prosthesis or previous endocarditis
  • Pregnancy, lactating women In case of severe coagulation disorders (platelet count < 30 G/L, International Normalized Ratio (INR) > 2) or heparin treatment or combined platelet inhibition treatment, the inclusion of the patient will be possible but digestive biopsies will not be allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digestive endoscopy
Performed a systematic œsophago-gastro-duodenoscopy during Intensive Care Unit stay after out-of-hospital cardiac arrest
Procedure: Digestive endoscopy
Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after out-of-hospital cardiac arrest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2014

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P13/30 ENTRACT
  • 2014-A00994-43 (Other Identifier: France : ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Out-of-hospital Cardiac Arrest

Clinical Trials on Digestive endoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe