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Sars-CoV2ACICOVIDNCT04373759

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

An observational study of Sars-CoV2 and Covid-19, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 36 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sars-CoV2, Covid-19
What is being tested?
Cardiopulmonary resuscitation and Modified Rankin score
How many people
186 participants
Where
36 sitesin 2 countries
Study dates
2 May 2020to 30 Sep 2020
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

France35 sites

  • CHU Amiens Picardie

    Amiens, Somme, 80000

  • CH Angoulème

    Angoulême, Charente, 16959

  • CH Argenteuil

    Argenteuil, Val-d'Oise, 95107

  • CH Bethune

    Beuvry, Pas-de-Calais, 62660

  • CHU Ambroise Paré AP-HP

    Boulogne-Billancourt, Hauts-de-Seine, 92100

  • CH Brive

    Brive-la-Gaillarde, Corrèze, 19100

  • CHU Caen

    Caen, Calvados, 14000

  • Hôpital Privé St Martin

    Caen, Calvados, 14000

  • CH Cahors

    Cahors, Lot, 46000

  • CHU Antoine Béclère AP-HP

    Clamart, Haut-de-Seine, 92140

  • CH Louis Mourier AP-HP

    Colombes, Hauts-de-Seine, 92700

  • CHU Henri Mondor AP-HP

    Créteil, Val-de-Marne, 94000

  • CHU Dijon

    Dijon, Côte-d'Or, 21000

  • CH de la Dracénie

    Draguignan, Var, 83300

  • CH Etampes

    Étampes, Essonne, 91150

  • CHI Frejus St Raphael

    Fréjus, Var, 83608

  • Grand Hôpital de l'Est Francilien

    Jossigny, Seine-et-Marne, 77600

  • CH Versailles

    Le Chesnay, Yvelines, 78150

  • CHU Kremlin Bicêtre

    Le Kremlin-Bicêtre, Val-de-Marne, 94270

  • CH Lens

    Lens, Pas-de-Calais, 62300

  • CHRU Roger Salengro

    Lille, Nord, 59037

  • CHU Meaux

    Meaux, Seine-et-Marne, 77100

  • Groupe Hospitalier Sud Ile de France

    Melun, Seine-et-Marne, 77000

  • CHU Montpellier

    Montpellier, Hérault, 34295

  • CHR Orléans

    Orléans, Loiret, 45010

  • CHU Lariboisière AP-HP

    Paris, Île-de-France Region, 75010

  • CHU Saint Louis AP-HP

    Paris, Île-de-France Region, 75010

  • CHU St Antoine

    Paris, Île-de-France Region, 75012

  • Groupe Hospitalier Saint Joseph

    Paris, Île-de-France Region, 75014

  • CHU Necker Enfants Malades

    Paris, Île-de-France Region, 75015

  • CHU Pitié Salpétrière

    Paris, Île-de-France Region, 75651

  • CHU Rouen

    Rouen, Seine-Maritime, 76000

  • CHU Felix Guyon

    Saint-Denis, La Reunion, 97405

  • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    Toulon, Var, 83056

  • Hôpital Nord Franche Comté

    Trévenans, Territoire De Belfort, 90400

Other trials in France

Martinique1 site

  • CHU Martinique - Fort de France

    Fort-de-France, 97200

Other trials in Martinique

About this study

Official title: 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 :

Read more
  • 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.

Read the 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.

Conditions
Sars-CoV2, Covid-19
Being tested
Cardiopulmonary resuscitation, Modified Rankin score
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
Medical subject headings
COVID-19, Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiopulmonary resuscitationOther

    Cardiopulmonary resuscitation

  • Modified Rankin scoreOther

    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
Study groups in NCT04373759
Study groupRoleWhat they receive
Unexpected in-intensive care unit cardiac arrest patientsICUCA Patients admitted in intensive care unit for a confirmed COVID-19 and presenting an unexpected in-intensive care unit cardiac arrest
Receives: Other: Cardiopulmonary resuscitation; Other: Modified Rankin score
In-hospital cardiac arrest patientsIHCA Patients admitted in intensive care unit for an in-hospital cardiac arrest with a confirmed Covid-19
Receives: Other: Modified Rankin score
Out-of-hospital cardiac arrestOHCA Patients admitted in intensive care unit for an out-hospital cardiac arrest with a confirmed Covid-19
Receives: Other: Modified Rankin score

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of unexpected cardiac arrest

    Percentage of unexpected in-intensive care unit cardiac arrest among COVID-19 patients admitted to intensive care unit

    Measured: 7 months

Secondary outcomes (4)

  1. Charlson score

    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.

    Measured: 7 months

  2. Organ failure score at ICU admission and/or before unexpected in-ICU cardiac arrest

    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

    Measured: 7 months

  3. Etiology retained to explain cardiac arrest occurrence

    Cardiac origin; Respiratory origin; Metabolic origin; unknown origin

    Measured: 7 months

  4. Modified Rankin score (mRS) at ICU discharge, at hospital discharge and at 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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2020
  2. Study start2 May 2020
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
186 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04373759
Sponsor's protocol ID
2020-CHITS-004
Acronym
ACICOVID
Status last verified
Oct 2022
First submitted
30 Apr 2020
Last updated
13 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31978945

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PubMed 32109013

  • Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.

    PubMed 32105632

  • Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

    PubMed 32250385

  • 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.

    PubMed 32152653

  • Bansal M. Cardiovascular disease and COVID-19. Diabetes Metab Syndr. 2020 May-Jun;14(3):247-250. doi: 10.1016/j.dsx.2020.03.013. Epub 2020 Mar 25.

    PubMed 32247212

  • Chen C, Zhou Y, Wang DW. SARS-CoV-2: a potential novel etiology of fulminant myocarditis. Herz. 2020 May;45(3):230-232. doi: 10.1007/s00059-020-04909-z. No abstract available.

    PubMed 32140732

  • Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.

    PubMed 32219356

  • Madjid M, Safavi-Naeini P, Solomon SD, Vardeny O. Potential Effects of Coronaviruses on the Cardiovascular System: A Review. JAMA Cardiol. 2020 Jul 1;5(7):831-840. doi: 10.1001/jamacardio.2020.1286.

    PubMed 32219363

  • Wu CI, Postema PG, Arbelo E, Behr ER, Bezzina CR, Napolitano C, Robyns T, Probst V, Schulze-Bahr E, Remme CA, Wilde AAM. SARS-CoV-2, COVID-19, and inherited arrhythmia syndromes. Heart Rhythm. 2020 Sep;17(9):1456-1462. doi: 10.1016/j.hrthm.2020.03.024. Epub 2020 Mar 31.

    PubMed 32244059

  • 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.

    PubMed 32283117

  • 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.

    PubMed 32255661

  • 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.

    PubMed 32224494

  • 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.

    PubMed 25438254

  • Chelly J, Plantefeve G, Kamel T, Bruel C, Nseir S, Lai C, Cirillo G, Skripkina E, Ehrminger S, Berdaguer-Ferrari FD, Le Marec J, Paul M, Autret A, Deye N; ACICOVID-19 study group. Incidence, clinical characteristics, and outcome after unexpected cardiac arrest among critically ill adults with COVID-19: insight from the multicenter prospective ACICOVID-19 registry. Ann Intensive Care. 2021 Nov 13;11(1):155. doi: 10.1186/s13613-021-00945-y.

    PubMed 34773516

Questions about this trial

What is this clinical trial studying?

An observational study of Sars-CoV2 and Covid-19, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 36 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of unexpected cardiac arrest (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04373759, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.

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