Clinical trial NCT04373759: Cardiac Arrest Incidence and Outcome Among Patients With COVID-19 in French ICUs
Official title: Cardiac Arrest Incidence and Outcome Among Patient With COVID-19 Pneumonia in French ICUs
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive adult patients admitted in intensive care unit with a documented SARS-CoV-2 disease

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.

Detailed description: Retrospective and prospective multicentric observational registry in French intensive care units (ICU) including all consecutive adult patients admitted in ICU with a documented SARS-CoV-2 disease :

* For an out-of-hospital or an in-hospital cardiac arrest (OHCA and IHCA respectively)
* Or presenting an unexpected in-ICU cardiac arrest (ICUCA) Patients characteristics, cardiac arrest history and patients outcome will be recorded according to Utstein recommendations.

Patients presenting an expected cardiac arrest in ICU related to withdrawal of life sustaining therapies (WLST) will be excluded.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of unexpected cardiac arrest
timeFrame: 7 months
Secondary outcomes:
measure: Charlson score
timeFrame: 7 months
measure: Organ failure score at ICU admission and/or before unexpected in-ICU cardiac arrest
timeFrame: 7 months
measure: Etiology retained to explain cardiac arrest occurrence
timeFrame: 7 months
measure: Modified Rankin score (mRS) at ICU discharge, at hospital discharge and at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
state: Calvados
city: Caen
country: France
facility: Hôpital Privé St Martin
state: Calvados
city: Angoulême
country: France
facility: CH Angoulème
state: Charente
city: Brive-la-Gaillarde
country: France
facility: CH Brive
state: Corrèze
city: Dijon
country: France
facility: CHU Dijon
state: Côte-d'Or
city: Étampes
country: France
facility: CH Etampes
state: Essonne
city: Clamart
country: France
facility: CHU Antoine Béclère AP-HP
state: Haut-de-Seine
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Paré AP-HP
state: Hauts-de-Seine
city: Colombes
country: France
facility: CH Louis Mourier AP-HP
state: Hauts-de-Seine
city: Montpellier
country: France
facility: CHU Montpellier
state: Hérault
city: Paris
country: France
facility: CHU Lariboisière AP-HP
state: Ile-de-France
city: Paris
country: France
facility: CHU Saint Louis AP-HP
state: Ile-de-France
city: Paris
country: France
facility: CHU St Antoine
state: Ile-de-France
city: Paris
country: France
facility: Groupe Hospitalier Saint Joseph
state: Ile-de-France
city: Paris
country: France
facility: CHU Necker Enfants Malades
state: Ile-de-France
city: Paris
country: France
facility: CHU Pitié Salpétrière
state: Ile-de-France
city: Saint-Denis
country: France
facility: CHU Felix Guyon
state: La Reunion
city: Orléans
country: France
facility: CHR Orléans
state: Loiret
city: Cahors
country: France
facility: CH Cahors
state: Lot
city: Lille
country: France
facility: CHRU Roger Salengro
state: Nord
city: Beuvry
country: France
facility: CH Bethune
state: Pas-de-Calais
city: Lens
country: France
facility: CH Lens
state: Pas-de-Calais
city: Jossigny
country: France
facility: Grand Hôpital de l'Est Francilien
state: Seine-et-Marne
city: Meaux
country: France
facility: CHU Meaux
state: Seine-et-Marne
city: Melun
country: France
facility: Groupe Hospitalier Sud Ile de France
state: Seine-et-Marne
city: Rouen
country: France
facility: CHU Rouen
state: Seine-Maritime
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Somme
city: Trévenans
country: France
facility: Hôpital Nord Franche Comté
state: Territoire De Belfort
city: Argenteuil
country: France
facility: CH Argenteuil
state: Val-d'Oise
city: Créteil
country: France
facility: CHU Henri Mondor AP-HP
state: Val-de-Marne
city: Le Kremlin-Bicêtre
country: France
facility: CHU Kremlin Bicêtre
state: Val-de-Marne
city: Draguignan
country: France
facility: CH de la Dracénie
state: Var
city: Fréjus
country: France
facility: CHI Frejus St Raphael
state: Var
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
city: Le Chesnay
country: France
facility: CH Versailles
state: Yvelines
city: Fort-de-France
country: Martinique
facility: CHU Martinique - Fort de France
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Jonathan Chelly, MD
role: STUDY_DIRECTOR
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