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

Covid-19 Clinical Trial

— ACICOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04373759
• Other study ID #: 2020-CHITS-004
• Status: Completed
• Start date: May 2, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Heart Arrest
• Sars-CoV2

Intervention

Other:
• Cardiopulmonary resuscitation
Cardiopulmonary resuscitation
• 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

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Somme
France	CH Angoulème	Angoulême	Charente
France	CH Argenteuil	Argenteuil	Val-d'Oise
France	CH Bethune	Beuvry	Pas-de-Calais
France	CHU Ambroise Paré AP-HP	Boulogne-Billancourt	Hauts-de-Seine
France	CH Brive	Brive-la-Gaillarde	Corrèze
France	CHU Caen	Caen	Calvados
France	Hôpital Privé St Martin	Caen	Calvados
France	CH Cahors	Cahors	Lot
France	CHU Antoine Béclère AP-HP	Clamart	Haut-de-Seine
France	CH Louis Mourier AP-HP	Colombes	Hauts-de-Seine
France	CHU Henri Mondor AP-HP	Créteil	Val-de-Marne
France	CHU Dijon	Dijon	Côte-d'Or
France	CH de la Dracénie	Draguignan	Var
France	CH Etampes	Étampes	Essonne
France	CHI Frejus St Raphael	Fréjus	Var
France	Grand Hôpital de l'Est Francilien	Jossigny	Seine-et-Marne
France	CH Versailles	Le Chesnay	Yvelines
France	CHU Kremlin Bicêtre	Le Kremlin-Bicêtre	Val-de-Marne
France	CH Lens	Lens	Pas-de-Calais
France	CHRU Roger Salengro	Lille	Nord
France	CHU Meaux	Meaux	Seine-et-Marne
France	Groupe Hospitalier Sud Ile de France	Melun	Seine-et-Marne
France	CHU Montpellier	Montpellier	Hérault
France	CHR Orléans	Orléans	Loiret
France	CHU Lariboisière AP-HP	Paris	Ile-de-France
France	CHU Necker Enfants Malades	Paris	Ile-de-France
France	CHU Pitié Salpétrière	Paris	Ile-de-France
France	CHU Saint Louis AP-HP	Paris	Ile-de-France
France	CHU St Antoine	Paris	Ile-de-France
France	Groupe Hospitalier Saint Joseph	Paris	Ile-de-France
France	CHU Rouen	Rouen	Seine-Maritime
France	CHU Felix Guyon	Saint-Denis	La Reunion
France	Centre Hospitalier Intercommunal Toulon La Seyne sur Mer	Toulon	Var
France	Hôpital Nord Franche Comté	Trévenans	Territoire De Belfort
Martinique	CHU Martinique - Fort de France	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Countries where clinical trial is conducted

France,  Martinique, 

References & Publications (15)

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Chelly J, Plantefève 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 a — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of unexpected cardiac arrest	Percentage of unexpected in-intensive care unit cardiac arrest among COVID-19 patients admitted to intensive care unit	7 months
Secondary	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.	7 months
Secondary	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	7 months
Secondary	Etiology retained to explain cardiac arrest occurrence	Cardiac origin; Respiratory origin; Metabolic origin; unknown origin	7 months
Secondary	Modified Rankin score (mRS) at ICU discharge, at hospital discharge and at 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	3 months