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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04373759
Recruitment Status : Completed
First Posted : May 4, 2020
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Study Description
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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.


Condition or disease Intervention/treatment
Sars-CoV2 Covid-19 Other: Cardiopulmonary resuscitation Other: Modified Rankin score

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 186 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Cardiac Arrest Incidence and Outcome Among Patient With COVID-19 Pneumonia in French ICUs
Actual Study Start Date : May 2, 2020
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Etiology retained to explain cardiac arrest occurrence [ Time Frame: 7 months ]
    Cardiac origin; Respiratory origin; Metabolic origin; unknown origin

  4. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive adult patients admitted in intensive care unit with a documented SARS-CoV-2 disease
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373759


Locations
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Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Investigators
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Study Director: Jonathan Chelly, MD Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
More Information
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Publications of Results:

Other Publications:
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, Gräsner 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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Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT04373759    
Other Study ID Numbers: 2020-CHITS-004
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:
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
Additional relevant MeSH terms:
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COVID-19
Heart Arrest
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases