Cardiac Arrest Incidence and Outcome Among Patients With COVID-19 in French ICUs

NCT04373759 | Completed

• 1 other identifier: 2020-CHITS-004
• Study Type: observational
• Target: 186
• Locations: 2 countries
• Sites: 36

Brief Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the novel coronavirus disease 2019 (COVID-19) pandemic. Among COVID-19 complications, in-hospital cardiac arrest (IHCA) was reported with a very poor outcome in a retrospective single-center study (0,7% of 30 days survival with good neurological outcome among IHCA patients with a resuscitation attempt), related to its natural course and management. The incidence of unexpected in-ICU cardiac arrest (ICUCA) due to COVID-19 is still unknown. Additionally, outcome of COVID-19 patients admitted in ICU for an out-of-hospital cardiac arrest (OHCA) is also undescribed. The objective this study is :

• to report the incidence of ICUCA among patients hospitalized in French ICU for COVID-19.
• to report morbidity and mortality among COVID-19 patients admitted alive in ICU for an OHCA or an IHCA. The secondary objective is to assess outcome and identify risk factors of ICUCA occurrence among patients admitted for COVID-19.

Conditions

Sars-CoV2; Covid-19

Keywords

novel coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); Out-of-hospital cardiac arrest; In-hospital cardiac arrest; unexpected cardiac arrest; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• Incidence of unexpected cardiac arrest

  Percentage of unexpected in-intensive care unit cardiac arrest among COVID-19 patients admitted to intensive care unit

  7 months

Secondary Outcomes (4)

• Charlson score

  7 months

• Organ failure score at ICU admission and/or before unexpected in-ICU cardiac arrest

  7 months

• Etiology retained to explain cardiac arrest occurrence

  7 months

• Modified Rankin score (mRS) at ICU discharge, at hospital discharge and at 3 months

  3 months

Study Arms (3)

Unexpected in-intensive care unit cardiac arrest patients

ICUCA Patients admitted in intensive care unit for a confirmed COVID-19 and presenting an unexpected in-intensive care unit cardiac arrest

Other: Cardiopulmonary resuscitation; Other: Modified Rankin score

In-hospital cardiac arrest patients

IHCA Patients admitted in intensive care unit for an in-hospital cardiac arrest with a confirmed Covid-19

Other: Modified Rankin score

Out-of-hospital cardiac arrest

OHCA Patients admitted in intensive care unit for an out-hospital cardiac arrest with a confirmed Covid-19

Other: Modified Rankin score

Interventions

Cardiopulmonary resuscitation OTHER

Cardiopulmonary resuscitation

Unexpected in-intensive care unit cardiac arrest patients

Modified Rankin score OTHER

0 - no symptoms at all 1. \- no significant disability despite symptoms; able to carry out all usual duties and activities 2. \- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. \- Moderate disability; requiring some help, but able to walk without assistance 4. \- Moderately severe disability; unable to walk and attend to bodily needs without assistance 5. \- Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. \- Dead

In-hospital cardiac arrest patients; Out-of-hospital cardiac arrest; Unexpected in-intensive care unit cardiac arrest patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive adult patients admitted in intensive care unit with a documented SARS-CoV-2 disease

You may qualify if:

• Patients admitted in intensive care unit with a documented SARS-CoV-2 disease
• For an out-of-hospital or an in-hospital cardiac arrest
• Or an in-hospital cardiac arrest
• Or presenting an unexpected in-intensive care unit cardiac arrest

You may not qualify if:

• Age under 18 y.o
• Expected in-intensive care unit cardiac arrest related to withdrawal of life sustaining therapies.
• Withdrawal of patient or next-of-kin informed consent

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (36)

CHU Caen

Caen, Calvados, 14000, France

Location

Hôpital Privé St Martin

Caen, Calvados, 14000, France

Location

CH Angoulème

Angoulême, Charente, 16959, France

Location

CH Brive

Brive-la-Gaillarde, Corrèze, 19100, France

Location

CHU Dijon

Dijon, Côte-d'Or, 21000, France

Location

CH Etampes

Étampes, Essonne, 91150, France

Location

CHU Antoine Béclère AP-HP

Clamart, Haut-de-Seine, 92140, France

Location

CHU Ambroise Paré AP-HP

Boulogne-Billancourt, Hauts-de-Seine, 92100, France

Location

CH Louis Mourier AP-HP

Colombes, Hauts-de-Seine, 92700, France

Location

CHU Montpellier

Montpellier, Hérault, 34295, France

Location

CHU Felix Guyon

Saint-Denis, La Reunion, 97405, France

Location

CHR Orléans

Orléans, Loiret, 45010, France

Location

CH Cahors

Cahors, Lot, 46000, France

Location

CHRU Roger Salengro

Lille, Nord, 59037, France

Location

CH Bethune

Beuvry, Pas-de-Calais, 62660, France

Location

CH Lens

Lens, Pas-de-Calais, 62300, France

Location

Grand Hôpital de l'Est Francilien

Jossigny, Seine-et-Marne, 77600, France

Location

CHU Meaux

Meaux, Seine-et-Marne, 77100, France

Location

Groupe Hospitalier Sud Ile de France

Melun, Seine-et-Marne, 77000, France

Location

CHU Rouen

Rouen, Seine-Maritime, 76000, France

Location

CHU Amiens Picardie

Amiens, Somme, 80000, France

Location

Hôpital Nord Franche Comté

Trévenans, Territoire De Belfort, 90400, France

Location

CH Argenteuil

Argenteuil, Val-d'Oise, 95107, France

Location

CHU Henri Mondor AP-HP

Créteil, Val-de-Marne, 94000, France

Location

CHU Kremlin Bicêtre

Le Kremlin-Bicêtre, Val-de-Marne, 94270, France

Location

CH de la Dracénie

Draguignan, Var, 83300, France

Location

CHI Frejus St Raphael

Fréjus, Var, 83608, France

Location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83056, France

Location

CH Versailles

Le Chesnay, Yvelines, 78150, France

Location

CHU Lariboisière AP-HP

Paris, Île-de-France Region, 75010, France

Location

CHU Saint Louis AP-HP

Paris, Île-de-France Region, 75010, France

Location

CHU St Antoine

Paris, Île-de-France Region, 75012, France

Location

Groupe Hospitalier Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

CHU Necker Enfants Malades

Paris, Île-de-France Region, 75015, France

Location

CHU Pitié Salpétrière

Paris, Île-de-France Region, 75651, France

Location

CHU Martinique - Fort de France

Fort-de-France, 97200, Martinique

Location

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MeSH Terms

Conditions

COVID-19; Out-of-Hospital Cardiac Arrest

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Resuscitation; Emergency Treatment; Therapeutics

Study Officials

• Jonathan Chelly, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 4, 2020
• Study Start: May 2, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); FR (35)