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

Primary Purpose

Out-of-hospital Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Digestive endoscopy
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Out-of-hospital Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Erasme
  • André Mignot Hospital, Intensive care unit
  • Cotentin Hospital, Medical intensive care unit
  • Hospital Louis Mourier
  • Sud Francilien Hospital, Medicla care unit
  • Henri Mondor Hospital, Medical Intensive care unit
  • Dupuytren hospital, Medical intensive care unit
  • Orléans Hospital, Medical intensive care unit
  • Cochin Hospital, Médical intensive care unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Digestive endoscopy

Arm Description

Performed a systematic œsophago-gastro-duodenoscopy during Intensive Care Unit stay after out-of-hospital cardiac arrest

Outcomes

Primary Outcome Measures

To measure the incidence of upper digestive macroscopic lesions after out-of-hospital cardiac arrest
Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after the cardiac arrest

Secondary Outcome Measures

Full Information

First Posted
January 22, 2015
Last Updated
May 23, 2022
Sponsor
Versailles Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02349074
Brief Title
Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT
Acronym
ENTRACT
Official Title
Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2014 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-hospital Cardiac Arrest

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digestive endoscopy
Arm Type
Experimental
Arm Description
Performed a systematic œsophago-gastro-duodenoscopy during Intensive Care Unit stay after out-of-hospital cardiac arrest
Intervention Type
Procedure
Intervention Name(s)
Digestive endoscopy
Intervention Description
Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after out-of-hospital cardiac arrest
Primary Outcome Measure Information:
Title
To measure the incidence of upper digestive macroscopic lesions after out-of-hospital cardiac arrest
Description
Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after the cardiac arrest
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Erasme
City
Brussels
Country
Belgium
Facility Name
André Mignot Hospital, Intensive care unit
City
Le chesnay
State/Province
Les Yvelines
ZIP/Postal Code
78150
Country
France
Facility Name
Cotentin Hospital, Medical intensive care unit
City
Cherbourg-Octeville
ZIP/Postal Code
50102
Country
France
Facility Name
Hospital Louis Mourier
City
Colombes
Country
France
Facility Name
Sud Francilien Hospital, Medicla care unit
City
Corbeil-Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
Henri Mondor Hospital, Medical Intensive care unit
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Dupuytren hospital, Medical intensive care unit
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Orléans Hospital, Medical intensive care unit
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
Cochin Hospital, Médical intensive care unit
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

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