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

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other)
• Overall Status: Completed
• CT.gov ID: NCT04373759
• Collaborator: (none)
• Enrollment: 186
• Locations: 36
• Actual Duration (Months): 5
• Patients Per Site: 5.2
• Patients Per Site Per Month: 1

Study Details

Study Description

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	Phase
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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 186 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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: Sep 30, 2020
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

Arm	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 - 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
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 - 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
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 - 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

Outcome Measures

Primary Outcome Measures

1. Incidence of unexpected cardiac arrest [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	CHU Caen	Caen	Calvados	France	14000
2	Hôpital Privé St Martin	Caen	Calvados	France	14000
3	CH Angoulème	Angoulême	Charente	France	16959
4	CH Brive	Brive-la-Gaillarde	Corrèze	France	19100
5	CHU Dijon	Dijon	Côte-d'Or	France	21000
6	CH Etampes	Étampes	Essonne	France	91150
7	CHU Antoine Béclère AP-HP	Clamart	Haut-de-Seine	France	92140
8	CHU Ambroise Paré AP-HP	Boulogne-Billancourt	Hauts-de-Seine	France	92100
9	CH Louis Mourier AP-HP	Colombes	Hauts-de-Seine	France	92700
10	CHU Montpellier	Montpellier	Hérault	France	34295
11	CHU Lariboisière AP-HP	Paris	Ile-de-France	France	75010
12	CHU Saint Louis AP-HP	Paris	Ile-de-France	France	75010
13	CHU St Antoine	Paris	Ile-de-France	France	75012
14	Groupe Hospitalier Saint Joseph	Paris	Ile-de-France	France	75014
15	CHU Necker Enfants Malades	Paris	Ile-de-France	France	75015
16	CHU Pitié Salpétrière	Paris	Ile-de-France	France	75651
17	CHU Felix Guyon	Saint-Denis	La Reunion	France	97405
18	CHR Orléans	Orléans	Loiret	France	45010
19	CH Cahors	Cahors	Lot	France	46000
20	CHRU Roger Salengro	Lille	Nord	France	59037
21	CH Bethune	Beuvry	Pas-de-Calais	France	62660
22	CH Lens	Lens	Pas-de-Calais	France	62300
23	Grand Hôpital de l'Est Francilien	Jossigny	Seine-et-Marne	France	77600
24	CHU Meaux	Meaux	Seine-et-Marne	France	77100
25	Groupe Hospitalier Sud Ile de France	Melun	Seine-et-Marne	France	77000
26	CHU Rouen	Rouen	Seine-Maritime	France	76000
27	CHU Amiens Picardie	Amiens	Somme	France	80000
28	Hôpital Nord Franche Comté	Trévenans	Territoire De Belfort	France	90400
29	CH Argenteuil	Argenteuil	Val-d'Oise	France	95107
30	CHU Henri Mondor AP-HP	Créteil	Val-de-Marne	France	94000
31	CHU Kremlin Bicêtre	Le Kremlin-Bicêtre	Val-de-Marne	France	94270
32	CH de la Dracénie	Draguignan	Var	France	83300
33	CHI Frejus St Raphael	Fréjus	Var	France	83608
34	Centre Hospitalier Intercommunal Toulon La Seyne sur Mer	Toulon	Var	France	83056
35	CH Versailles	Le Chesnay	Yvelines	France	78150
36	CHU Martinique - Fort de France	Fort-de-France		Martinique	97200

Sponsors and Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

• Study Director: Jonathan Chelly, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• 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.
• 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.
• 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. Erratum in: JAMA. 2021 May 25;325(20):2120.
• 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.
• 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. Erratum in: JAMA Cardiol. 2020 Jul 1;5(7):848.
• 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.
• 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. Review.
• 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.
• 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.
• 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.
• 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. Review.
• 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. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26.
• 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.

• 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
• Last Update Posted: Feb 15, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: COVID-19; Heart Arrest

Study Results

No Results Posted as of Feb 15, 2022