Unexpected Cardiac Arrest in Intensive Care Unit

NCT ID: NCT03021564

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 677 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-06-30

Brief Summary

Unexpected cardiac arrest involves approximately 0.5 to 5% of patients admitted in Intensive Care Unit (ICU). Even if they have a technical environment conducive to prompt diagnosis and prompt treatment, patients hospitalized in ICU suffer from chronic illnesses and organ failure(s) that obscure the prognosis of cardiac arrest. Although extra cardiac arrhythmias or intra-hospital arrests are the subject of numerous publications, few studies specifically focus on unexpected cardiac arrest in ICU (none in France). The objective of our work is to produce a prospective epidemiological description of unexpected cardiac arrest in in French ICUs.

Detailed Description

Unexpected cardiac arrest in ICU corresponds to cardiovascular arrest leading to at least one cardiopulmonary resuscitation technique (external cardiac massage and / or electric shock). They account for about 0.5 to 5% of admissions to intensive care units. Even if they benefit from a technical environment conducive to prompt diagnosis and rapid management, Resuscitated patients suffer from chronic diseases and organ failure (s) that darken the prognosis. Etiologies of unexpected cardiac arrest in ICU are rarely described in the literature. Their specificity comes from the fact that they can be related to patient's medical characteristics, but also to deleterious effects of supportive techniques in place at the time of circulatory arrest (respiratory assistance, vasopressor drugs, extracorporeal circulation ...). These same techniques may also reduce the effectiveness of cardiopulmonary resuscitation (cardiorespiratory interactions of respiratory assistance, pro-arrhythmogenic effect of vasopressor drugs, haemodynamic repercussion of extracorporeal circulation). Although cardiac arrests have been published extensively out of or in-hospital, there are few studies specifically concerning unexpected cardiac arrest in ICU (none in France). The prognosis is different: after an unexpected cardiac arrest in ICU, 50% of the patients recover a spontaneous cardiac activity but only 15% leave alive from the hospital (3 to 4% with a good functional autonomy). A prospective description of risk factors, circumstances and consequences in the medium term would identify (and prevent) risky situations and identify, among those at risk for unexpected cardiac arrest, those for whom a cardiopulmonary resuscitation is justified.

Conditions

Heart Arrest

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

cardiopulmonary resuscitation

Basic cardiopulmonary resuscitation : external electric shock, external cardiac massage, adrenaline injection ...

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient with unexpected cardiac arrest during his / her hospitalization in the ICU
• Patients who have benefited from at least one basic cardiopulmonary resuscitation technique by the ICU team to treat this circulatory arrest (external electric shock, external cardiac massage, adrenaline injection ...)
• Patients with multiple unexpected cardiac arrest during hospitalization will be included only for the first circulatory arrest.

Exclusion Criteria

• Patients with unexpected cardiac that have not been resuscitated.
• Patients in cardiac arrest at admission to ICU

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier de la Rochelle Ré Aunis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxime Leloup, MD

Role: STUDY_DIRECTOR

Groupe Hospitalier de la Rochelle Ré Aunis

Locations

CH Agen

Agen, , France

CHU Angers

Angers, , France

CH Angouleme

Angoulême, , France

CH Angoulême

Angoulême, , France

CH Arras

Arras, , France

GH Carnelle Portes de l'Oise

Beaumont, , France

CH Béthune

Béthune, , France

CH Blois

Blois, , France

APHP

Bobigny, , France

CH Bourg en Bresse

Bourg-en-Bresse, , France

CHU Brest

Brest, , France

CHU Caen

Caen, , France

CH Cahors

Cahors, , France

CH Chartres

Chartres, , France

CH Cholet

Cholet, , France

CH Colmar

Colmar, , France

CH Dieppe

Dieppe, , France

CHU Dijon

Dijon, , France

CH Sud Essonnes

Étampes, , France

APHP

Garches, , France

CHU Grenoble

Grenoble, , France

CH Gueret

Guéret, , France

CHU La Réunion

La Réunion, , France

CHD Vendée

La Roche-sur-Yon, , France

GH La Rochelle Ré Aunis

La Rochelle, , France

CH Lens

Lens, , France

GH de l'Institut Catholique de Lille

Lille, , France

CHU Limoges

Limoges, , France

CHU Lyon

Lyon, , France

CH Meaux

Meaux, , France

CH Melun

Melun, , France

CHU Nantes

Nantes, , France

CH Niort

Niort, , France

CHU Nîmes

Nîmes, , France

CHR Orleans

Orléans, , France

APHP Cochin

Paris, , France

APHP Saint Louis

Paris, , France

Hôpital Paris Saint Joseph

Paris, , France

CH Pau

Pau, , France

CHU Poitiers

Poitiers, , France

CH Pontoise

Pontoise, , France

CH Cornouaille

Quimper, , France

CH Roanne

Roanne, , France

CHU Rouen

Rouen, , France

CH Versailles

Versailles, , France

Countries

France

References

Rozen TH, Mullane S, Kaufman M, Hsiao YF, Warrillow S, Bellomo R, Jones DA. Antecedents to cardiac arrests in a teaching hospital intensive care unit. Resuscitation. 2014 Mar;85(3):411-7. doi: 10.1016/j.resuscitation.2013.11.018. Epub 2013 Dec 8.

Reference Type: BACKGROUND

PMID: 24326274 (View on PubMed)

Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: a physiologically based classification system. Crit Care Med. 1981 Aug;9(8):591-7. doi: 10.1097/00003246-198108000-00008.

Reference Type: BACKGROUND

PMID: 7261642 (View on PubMed)

Synek VM. EEG abnormality grades and subdivisions of prognostic importance in traumatic and anoxic coma in adults. Clin Electroencephalogr. 1988 Jul;19(3):160-6. doi: 10.1177/155005948801900310.

Reference Type: BACKGROUND

PMID: 3416501 (View on PubMed)

Myrianthefs P, Kalafati M, Lemonidou C, Minasidou E, Evagelopoulou P, Karatzas S, Baltopoulos G. Efficacy of CPR in a general, adult ICU. Resuscitation. 2003 Apr;57(1):43-8. doi: 10.1016/s0300-9572(02)00432-x.

Reference Type: BACKGROUND

PMID: 12668298 (View on PubMed)

Lesieur O, Leloup M, Gonzalez F, Mamzer MF; EPILAT Study Group. Eligibility for organ donation following end-of-life decisions: a study performed in 43 French intensive care units. Intensive Care Med. 2014 Sep;40(9):1323-31. doi: 10.1007/s00134-014-3409-2. Epub 2014 Aug 5.

Reference Type: BACKGROUND

PMID: 25091789 (View on PubMed)

Lee HK, Lee H, No JM, Jeon YT, Hwang JW, Lim YJ, Park HP. Factors influencing outcome in patients with cardiac arrest in the ICU. Acta Anaesthesiol Scand. 2013 Jul;57(6):784-92. doi: 10.1111/aas.12117. Epub 2013 Mar 31.

Reference Type: BACKGROUND

PMID: 23550795 (View on PubMed)

Peterson MW, Geist LJ, Schwartz DA, Konicek S, Moseley PL. Outcome after cardiopulmonary resuscitation in a medical intensive care unit. Chest. 1991 Jul;100(1):168-74. doi: 10.1378/chest.100.1.168.

Reference Type: BACKGROUND

PMID: 2060338 (View on PubMed)

Enohumah KO, Moerer O, Kirmse C, Bahr J, Neumann P, Quintel M. Outcome of cardiopulmonary resuscitation in intensive care units in a university hospital. Resuscitation. 2006 Nov;71(2):161-70. doi: 10.1016/j.resuscitation.2006.03.013. Epub 2006 Sep 20.

Reference Type: BACKGROUND

PMID: 16989937 (View on PubMed)

Landry FJ, Parker JM, Phillips YY. Outcome of cardiopulmonary resuscitation in the intensive care setting. Arch Intern Med. 1992 Nov;152(11):2305-8.

Reference Type: BACKGROUND

PMID: 1444691 (View on PubMed)

Tian J, Kaufman DA, Zarich S, Chan PS, Ong P, Amoateng-Adjepong Y, Manthous CA; American Heart Association National Registry for Cardiopulmonary Resuscitation Investigators. Outcomes of critically ill patients who received cardiopulmonary resuscitation. Am J Respir Crit Care Med. 2010 Aug 15;182(4):501-6. doi: 10.1164/rccm.200910-1639OC. Epub 2010 Apr 22.

Reference Type: BACKGROUND

PMID: 20413625 (View on PubMed)

Kutsogiannis DJ, Bagshaw SM, Laing B, Brindley PG. Predictors of survival after cardiac or respiratory arrest in critical care units. CMAJ. 2011 Oct 4;183(14):1589-95. doi: 10.1503/cmaj.100034. Epub 2011 Aug 15.

Reference Type: BACKGROUND

PMID: 21844108 (View on PubMed)

Smith DL, Kim K, Cairns BA, Fakhry SM, Meyer AA. Prospective analysis of outcome after cardiopulmonary resuscitation in critically ill surgical patients. J Am Coll Surg. 1995 Apr;180(4):394-401.

Reference Type: BACKGROUND

PMID: 7719542 (View on PubMed)

Cummins RO, Chamberlain D, Hazinski MF, Nadkarni V, Kloeck W, Kramer E, Becker L, Robertson C, Koster R, Zaritsky A, Bossaert L, Ornato JP, Callanan V, Allen M, Steen P, Connolly B, Sanders A, Idris A, Cobbe S. Recommended guidelines for reviewing, reporting, and conducting research on in-hospital resuscitation: the in-hospital 'Utstein style'. American Heart Association. Circulation. 1997 Apr 15;95(8):2213-39. doi: 10.1161/01.cir.95.8.2213. No abstract available.

Reference Type: BACKGROUND

PMID: 9133537 (View on PubMed)

Langhelle A, Nolan J, Herlitz J, Castren M, Wenzel V, Soreide E, Engdahl J, Steen PA; 2003 Utstein Consensus Symposium. Recommended guidelines for reviewing, reporting, and conducting research on post-resuscitation care: the Utstein style. Resuscitation. 2005 Sep;66(3):271-83. doi: 10.1016/j.resuscitation.2005.06.005.

Reference Type: BACKGROUND

PMID: 16129543 (View on PubMed)

Gershengorn HB, Li G, Kramer A, Wunsch H. Survival and functional outcomes after cardiopulmonary resuscitation in the intensive care unit. J Crit Care. 2012 Aug;27(4):421.e9-17. doi: 10.1016/j.jcrc.2011.11.001. Epub 2012 Jan 9.

Reference Type: BACKGROUND

PMID: 22227081 (View on PubMed)

Skrifvars MB, Varghese B, Parr MJ. Survival and outcome prediction using the Apache III and the out-of-hospital cardiac arrest (OHCA) score in patients treated in the intensive care unit (ICU) following out-of-hospital, in-hospital or ICU cardiac arrest. Resuscitation. 2012 Jun;83(6):728-33. doi: 10.1016/j.resuscitation.2011.11.036. Epub 2012 Jan 25.

Reference Type: BACKGROUND

PMID: 22281225 (View on PubMed)

Efendijev I, Raj R, Reinikainen M, Hoppu S, Skrifvars MB. Temporal trends in cardiac arrest incidence and outcome in Finnish intensive care units from 2003 to 2013. Intensive Care Med. 2014 Dec;40(12):1853-61. doi: 10.1007/s00134-014-3509-z. Epub 2014 Nov 12.

Reference Type: BACKGROUND

PMID: 25387815 (View on PubMed)

Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

Reference Type: BACKGROUND

PMID: 8844239 (View on PubMed)

Lesieur O, Leloup M, Gonzalez F, Mamzer MF; EPILAT study group. Withholding or withdrawal of treatment under French rules: a study performed in 43 intensive care units. Ann Intensive Care. 2015 Dec;5(1):56. doi: 10.1186/s13613-015-0056-x. Epub 2015 Jun 19.

Reference Type: BACKGROUND

PMID: 26092498 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32152653 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2015/P04/049

Identifier Type: -

Identifier Source: org_study_id