Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

NCT ID: NCT02349074

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-12
• Study Completion Date: 2019-09-01

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.

Conditions

Out-of-hospital Cardiac Arrest

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Digestive endoscopy

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

Group Type: EXPERIMENTAL

Digestive endoscopy

Intervention Type: PROCEDURE

Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after out-of-hospital cardiac arrest

Interventions

Digestive endoscopy

Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after out-of-hospital cardiac arrest

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr David GRIMALDI

Investigator coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Erasme

Brussels, , Belgium

André Mignot Hospital, Intensive care unit

Le Chesnay, Les Yvelines, France

Cotentin Hospital, Medical intensive care unit

Cherbourg-Octeville, , France

Hospital Louis Mourier

Colombes, , France

Sud Francilien Hospital, Medicla care unit

Corbeil-Essonnes, , France

Henri Mondor Hospital, Medical Intensive care unit

Créteil, , France

Dupuytren hospital, Medical intensive care unit

Limoges, , France

Orléans Hospital, Medical intensive care unit

Orléans, , France

Cochin Hospital, Médical intensive care unit

Paris, , France

Countries

Belgium; France

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Other Identifiers

2014-A00994-43

Identifier Type: OTHER

Identifier Source: secondary_id

P13/30 ENTRACT

Identifier Type: -

Identifier Source: org_study_id