Cardiac Arrest Incidence and Outcome Among Patients With COVID-19 in French ICUs
NCT ID: NCT04373759
Last Updated: 2022-10-13
Study Results
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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COMPLETED
186 participants
OBSERVATIONAL
2020-05-02
2020-09-30
Brief Summary
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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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Detailed Description
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* 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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Study Design
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COHORT
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
Cardiopulmonary resuscitation
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
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
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
Interventions
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Cardiopulmonary resuscitation
Cardiopulmonary resuscitation
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Expected in-intensive care unit cardiac arrest related to withdrawal of life sustaining therapies.
* Withdrawal of patient or next-of-kin informed consent
18 Years
ALL
No
Sponsors
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
OTHER
Responsible Party
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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
Hôpital Privé St Martin
Caen, Calvados, France
CH Angoulème
Angoulême, Charente, France
CH Brive
Brive-la-Gaillarde, Corrèze, France
CHU Dijon
Dijon, Côte-d'Or, France
CH Etampes
Étampes, Essonne, France
CHU Antoine Béclère AP-HP
Clamart, Haut-de-Seine, France
CHU Ambroise Paré AP-HP
Boulogne-Billancourt, Hauts-de-Seine, France
CH Louis Mourier AP-HP
Colombes, Hauts-de-Seine, France
CHU Montpellier
Montpellier, Hérault, France
CHU Felix Guyon
Saint-Denis, La Reunion, France
CHR Orléans
Orléans, Loiret, France
CH Cahors
Cahors, Lot, France
CHRU Roger Salengro
Lille, Nord, France
CH Bethune
Beuvry, Pas-de-Calais, France
CH Lens
Lens, Pas-de-Calais, France
Grand Hôpital de l'Est Francilien
Jossigny, Seine-et-Marne, France
CHU Meaux
Meaux, Seine-et-Marne, France
Groupe Hospitalier Sud Ile de France
Melun, Seine-et-Marne, France
CHU Rouen
Rouen, Seine-Maritime, France
CHU Amiens Picardie
Amiens, Somme, France
Hôpital Nord Franche Comté
Trévenans, Territoire De Belfort, France
CH Argenteuil
Argenteuil, Val-d'Oise, France
CHU Henri Mondor AP-HP
Créteil, Val-de-Marne, France
CHU Kremlin Bicêtre
Le Kremlin-Bicêtre, Val-de-Marne, France
CH de la Dracénie
Draguignan, Var, France
CHI Frejus St Raphael
Fréjus, Var, France
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, France
CH Versailles
Le Chesnay, Yvelines, France
CHU Lariboisière AP-HP
Paris, Île-de-France Region, France
CHU Saint Louis AP-HP
Paris, Île-de-France Region, France
CHU St Antoine
Paris, Île-de-France Region, France
Groupe Hospitalier Saint Joseph
Paris, Île-de-France Region, France
CHU Necker Enfants Malades
Paris, Île-de-France Region, France
CHU Pitié Salpétrière
Paris, Île-de-France Region, France
CHU Martinique - Fort de France
Fort-de-France, , Martinique
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2020-CHITS-004
Identifier Type: -
Identifier Source: org_study_id
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