Clinical trial NCT03021564: Unexpected Cardiac Arrest in Intensive Care Unit
Official title: Prospective Multi-centre Observational Study on the Epidemiology, Risk Factors and Consequences of Unexpected Cardiac Arrest in Intensive Care Units.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrest
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 677
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in intensive care unit during the study period and presenting an unexpected cardiac arrest will be included

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.

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

Primary outcomes:
measure: Number of Patients With Unexpected Cardiac Arrest
timeFrame: 1 year
Secondary outcomes:
measure: Number of Patients Per Reason for ICU Admission
timeFrame: 1 year
measure: History, Comorbidities Before Unexpected Cardiac Arrest
timeFrame: 1 year
measure: Mc Cabe Score Before Unexpected Cardiac Arrest
timeFrame: 1 year
measure: Knaus Score Before Unexpected Cardiac Arrest
timeFrame: 1 year
measure: Organ Failure Score Before Unexpected Cardiac Arrest
timeFrame: 1 year
measure: Number of Participants With Unexpected Cardiac Arrest Etiologies
timeFrame: 1 year
measure: Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation
timeFrame: 1 year
measure: Cerebral Performance Category Scale at Hospital Discharge
timeFrame: at Hospital Discharge
measure: Cerebral Performance Category Scale at 6 Months
timeFrame: at 6 months after inclusion (unexpected cardiac arrest)
measure: Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate
timeFrame: 1 year
Other outcomes:
Locations:
city: Agen
country: France
facility: CH Agen
city: Angers
country: France
facility: CHU Angers
city: Angouleme
country: France
facility: CH Angouleme
city: Angouleme
country: France
facility: CH Angoulême
city: Arras
country: France
facility: CH Arras
city: Beaumont
country: France
facility: GH Carnelle Portes de l'Oise
city: Bethune
country: France
facility: CH Béthune
city: Blois
country: France
facility: CH Blois
city: Bobigny
country: France
facility: APHP
city: Bourg en Bresse
country: France
facility: CH Bourg en Bresse
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: CHU Caen
city: Cahors
country: France
facility: CH Cahors
city: Chartres
country: France
facility: CH Chartres
city: Cholet
country: France
facility: CH Cholet
city: Colmar
country: France
facility: CH Colmar
city: Dieppe
country: France
facility: CH Dieppe
city: Dijon
country: France
facility: CHU Dijon
city: Etampes
country: France
facility: CH Sud Essonnes
city: Garches
country: France
facility: APHP
city: Grenoble
country: France
facility: CHU Grenoble
city: Gueret
country: France
facility: CH Gueret
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: GH La Rochelle Ré Aunis
city: La Réunion
country: France
facility: CHU La Réunion
city: Lens
country: France
facility: CH Lens
city: Lille
country: France
facility: GH de l'Institut Catholique de Lille
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: CHU Lyon
city: Meaux
country: France
facility: CH Meaux
city: Melun
country: France
facility: CH Melun
city: Nantes
country: France
facility: CHU Nantes
city: Niort
country: France
facility: CH Niort
city: Nîmes
country: France
facility: CHU Nîmes
city: Orleans
country: France
facility: CHR Orleans
city: Paris
country: France
facility: APHP Cochin
city: Paris
country: France
facility: APHP Saint Louis
city: Paris
country: France
facility: Hôpital Paris Saint Joseph
city: Pau
country: France
facility: CH Pau
city: Poitiers
country: France
facility: CHU Poitiers
city: Pontoise
country: France
facility: CH Pontoise
city: Quimper
country: France
facility: CH Cornouaille
city: Roanne
country: France
facility: CH Roanne
city: Rouen
country: France
facility: CHU Rouen
city: Versailles
country: France
facility: CH Versailles
Study officials:
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Maxime Leloup, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Landry FJ, Parker JM, Phillips YY. Outcome of cardiopulmonary resuscitation in the intensive care setting. Arch Intern Med. 1992 Nov;152(11):2305-8.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.