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

NCT ID: NCT04373759

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-02

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Sars-CoV2 Covid-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Cardiopulmonary resuscitation

Intervention Type OTHER

Cardiopulmonary resuscitation

Modified Rankin score

Intervention Type 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

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

Modified Rankin score

Intervention Type 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

Out-of-hospital cardiac arrest

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

Modified Rankin score

Intervention Type 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

Interventions

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Cardiopulmonary resuscitation

Cardiopulmonary resuscitation

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Chelly, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Locations

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CHU Caen

Caen, Calvados, France

Site Status

Hôpital Privé St Martin

Caen, Calvados, France

Site Status

CH Angoulème

Angoulême, Charente, France

Site Status

CH Brive

Brive-la-Gaillarde, Corrèze, France

Site Status

CHU Dijon

Dijon, Côte-d'Or, France

Site Status

CH Etampes

Étampes, Essonne, France

Site Status

CHU Antoine Béclère AP-HP

Clamart, Haut-de-Seine, France

Site Status

CHU Ambroise Paré AP-HP

Boulogne-Billancourt, Hauts-de-Seine, France

Site Status

CH Louis Mourier AP-HP

Colombes, Hauts-de-Seine, France

Site Status

CHU Montpellier

Montpellier, Hérault, France

Site Status

CHU Felix Guyon

Saint-Denis, La Reunion, France

Site Status

CHR Orléans

Orléans, Loiret, France

Site Status

CH Cahors

Cahors, Lot, France

Site Status

CHRU Roger Salengro

Lille, Nord, France

Site Status

CH Bethune

Beuvry, Pas-de-Calais, France

Site Status

CH Lens

Lens, Pas-de-Calais, France

Site Status

Grand Hôpital de l'Est Francilien

Jossigny, Seine-et-Marne, France

Site Status

CHU Meaux

Meaux, Seine-et-Marne, France

Site Status

Groupe Hospitalier Sud Ile de France

Melun, Seine-et-Marne, France

Site Status

CHU Rouen

Rouen, Seine-Maritime, France

Site Status

CHU Amiens Picardie

Amiens, Somme, France

Site Status

Hôpital Nord Franche Comté

Trévenans, Territoire De Belfort, France

Site Status

CH Argenteuil

Argenteuil, Val-d'Oise, France

Site Status

CHU Henri Mondor AP-HP

Créteil, Val-de-Marne, France

Site Status

CHU Kremlin Bicêtre

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

Site Status

CH de la Dracénie

Draguignan, Var, France

Site Status

CHI Frejus St Raphael

Fréjus, Var, France

Site Status

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, France

Site Status

CH Versailles

Le Chesnay, Yvelines, France

Site Status

CHU Lariboisière AP-HP

Paris, Île-de-France Region, France

Site Status

CHU Saint Louis AP-HP

Paris, Île-de-France Region, France

Site Status

CHU St Antoine

Paris, Île-de-France Region, France

Site Status

Groupe Hospitalier Saint Joseph

Paris, Île-de-France Region, France

Site Status

CHU Necker Enfants Malades

Paris, Île-de-France Region, France

Site Status

CHU Pitié Salpétrière

Paris, Île-de-France Region, France

Site Status

CHU Martinique - Fort de France

Fort-de-France, , Martinique

Site Status

Countries

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France Martinique

References

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Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

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Leloup M, Briatte I, Langlois A, Cariou A, Lesieur O; ACIR study group. Unexpected cardiac arrests occurring inside the ICU: outcomes of a French prospective multicenter study. Intensive Care Med. 2020 May;46(5):1005-1015. doi: 10.1007/s00134-020-05992-w. Epub 2020 Mar 9.

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Shao F, Xu S, Ma X, Xu Z, Lyu J, Ng M, Cui H, Yu C, Zhang Q, Sun P, Tang Z. In-hospital cardiac arrest outcomes among patients with COVID-19 pneumonia in Wuhan, China. Resuscitation. 2020 Jun;151:18-23. doi: 10.1016/j.resuscitation.2020.04.005. Epub 2020 Apr 10.

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Chan PS, Berg RA, Nadkarni VM. Code Blue During the COVID-19 Pandemic. Circ Cardiovasc Qual Outcomes. 2020 May;13(5):e006779. doi: 10.1161/CIRCOUTCOMES.120.006779. Epub 2020 Apr 7.

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Mahase E, Kmietowicz Z. Covid-19: Doctors are told not to perform CPR on patients in cardiac arrest. BMJ. 2020 Mar 29;368:m1282. doi: 10.1136/bmj.m1282. No abstract available.

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Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, Bossaert LL, Brett SJ, Chamberlain D, de Caen AR, Deakin CD, Finn JC, Grasner JT, Hazinski MF, Iwami T, Koster RW, Lim SH, Ma MH, McNally BF, Morley PT, Morrison LJ, Monsieurs KG, Montgomery W, Nichol G, Okada K, Ong ME, Travers AH, Nolan JP; Utstein Collaborators. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: A Statement for Healthcare Professionals From a Task Force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Resuscitation. 2015 Nov;96:328-40. doi: 10.1016/j.resuscitation.2014.11.002. Epub 2014 Nov 11.

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Reference Type RESULT
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Other Identifiers

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2020-CHITS-004

Identifier Type: -

Identifier Source: org_study_id

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