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

October 12, 2022 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

186

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

  • France
    • Calvados
      • Caen, Calvados, France, 14000
        • CHU Caen
      • Caen, Calvados, France, 14000
        • Hôpital Privé St Martin
    • Charente
      • Angoulême, Charente, France, 16959
        • CH Angoulême
    • Corrèze
      • Brive-la-Gaillarde, Corrèze, France, 19100
        • CH BRIVE
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21000
        • CHU Dijon
    • Essonne
      • Étampes, Essonne, France, 91150
        • CH Etampes
    • Haut-de-Seine
      • Clamart, Haut-de-Seine, France, 92140
        • CHU Antoine Béclère AP-HP
    • Hauts-de-Seine
      • Boulogne-Billancourt, Hauts-de-Seine, France, 92100
        • CHU Ambroise Paré AP-HP
      • Colombes, Hauts-de-Seine, France, 92700
        • CH Louis Mourier AP-HP
    • Hérault
      • Montpellier, Hérault, France, 34295
        • CHU Montpellier
    • Ile-de-France
      • Paris, Ile-de-France, France, 75010
        • CHU Lariboisière AP-HP
      • Paris, Ile-de-France, France, 75010
        • CHU Saint Louis AP-HP
      • Paris, Ile-de-France, France, 75012
        • CHU St Antoine
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Saint Joseph
      • Paris, Ile-de-France, France, 75015
        • CHU Necker Enfants Malades
      • Paris, Ile-de-France, France, 75651
        • CHU Pitié Salpétrière
    • La Reunion
      • Saint-Denis, La Reunion, France, 97405
        • CHU Felix Guyon
    • Loiret
      • Orléans, Loiret, France, 45010
        • CHR Orléans
    • Lot
      • Cahors, Lot, France, 46000
        • CH Cahors
    • Nord
      • Lille, Nord, France, 59037
        • CHRU Roger Salengro
    • Pas-de-Calais
      • Beuvry, Pas-de-Calais, France, 62660
        • CH Bethune
      • Lens, Pas-de-Calais, France, 62300
        • CH LENS
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76000
        • CHU Rouen
    • Seine-et-Marne
      • Jossigny, Seine-et-Marne, France, 77600
        • Grand Hôpital de l'Est Francilien
      • Meaux, Seine-et-Marne, France, 77100
        • CHU Meaux
      • Melun, Seine-et-Marne, France, 77000
        • Groupe Hospitalier Sud Ile de France
    • Somme
      • Amiens, Somme, France, 80000
        • CHU Amiens Picardie
    • Territoire De Belfort
      • Trévenans, Territoire De Belfort, France, 90400
        • Hopital Nord Franche Comte
    • Val-d'Oise
      • Argenteuil, Val-d'Oise, France, 95107
        • CH Argenteuil
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94000
        • CHU Henri Mondor AP-HP
      • Le Kremlin-Bicêtre, Val-de-Marne, France, 94270
        • CHU Kremlin Bicêtre
    • Var
      • Draguignan, Var, France, 83300
        • CH de la Dracénie
      • Fréjus, Var, France, 83608
        • CHI Fréjus St Raphaël
      • Toulon, Var, France, 83056
        • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
    • Yvelines
      • Le Chesnay, Yvelines, France, 78150
        • CH Versailles
  • Martinique
      • Fort-de-France, Martinique, 97200
        • CHU Martinique - Fort de France

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

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Cardiopulmonary resuscitation
Other: Modified Rankin score

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
IHCA Patients admitted in intensive care unit for an in-hospital cardiac arrest with a confirmed Covid-19
Other: Modified Rankin score

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
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of unexpected cardiac arrest
Time Frame: 7 months
Percentage of unexpected in-intensive care unit cardiac arrest among COVID-19 patients admitted to intensive care unit
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Charlson score
Time Frame: 7 months
Diabetes, hypertension, smoking, dyslipidemia, coronary artery disease, chronic respiratory insufficiency, chronic heart failure, chronic renal insufficiency, chronic hepatic insufficiency, chronic neurological disease, cancer, malignant hemopathy. Charlson score's minimum and maximum values are 0 and 40 respectively, the lowest score corresponds to a better outcome.
7 months
Organ failure score at ICU admission and/or before unexpected in-ICU cardiac arrest
Time Frame: 7 months
Respiratory failure, neurological impairment, circulatory failure, hepatic failure, haematological failure, renal failure. Sofa score's minimum and maximum values are 0 and 24, the lowest score corresponds to a better outcome
7 months
Etiology retained to explain cardiac arrest occurrence
Time Frame: 7 months
Cardiac origin; Respiratory origin; Metabolic origin; unknown origin
7 months
Modified Rankin score (mRS) at ICU discharge, at hospital discharge and at 3 months
Time Frame: 3 months

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
3 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

  • Study Director: Jonathan Chelly, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

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)

May 2, 2020

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

September 30, 2020

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (ACTUAL)

May 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-CHITS-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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