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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04373759
Other study ID # 2020-CHITS-004
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in allClick 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
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