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NCT Number: NCT04373759

Cardiac Arrest Incidence and Outcome Among Patients With COVID-19 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.

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Key information

Conditions

Sars-CoV2 COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Heart Arrest Heart Diseases Infections Lung Diseases Nidovirales Infections Out-of-Hospital Cardiac Arrest Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Caen, Caen, Calvados, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiopulmonary resuscitation

Other

Cardiopulmonary resuscitation

Modified Rankin score

Other

0 - no symptoms at all

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

Primary outcomes

  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 outcomes

  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

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

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

Acronym: ACICOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 4, 2020
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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