Unexpected Cardiac Arrest in Intensive Care Unit

Heart Arrest Clinical Trial

— ACIR  

Official title:

Prospective Multi-centre Observational Study on the Epidemiology, Risk Factors and Consequences of Unexpected Cardiac Arrest in Intensive Care Units.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021564
• Other study ID #: 2015/P04/049
• Status: Completed
• Start date: January 2017
• Est. completion date: June 2018

Study information

• Verified date: July 2020
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest

Intervention

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

Locations

Country	Name	City	State
France	CH Agen	Agen
France	CHU Angers	Angers
France	CH Angouleme	Angouleme
France	CH Angoulême	Angouleme
France	CH Arras	Arras
France	GH Carnelle Portes de l'Oise	Beaumont
France	CH Béthune	Bethune
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	Etampes
France	APHP	Garches
France	CHU Grenoble	Grenoble
France	CH Gueret	Gueret
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	CHU Nîmes	Nîmes
France	CH Niort	Niort
France	CHR Orleans	Orleans
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

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis

Country where clinical trial is conducted

France, 

References & Publications (20)

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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. — View 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. Epub 2006 Sep 20. — View 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. — View Citation

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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. — 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. — View 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. — View 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. — View 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. — View Citation

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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. — View 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. Erratum in: Resuscitation. 2013 Mar;84(3):395-6. — View 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. — View Citation

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Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Unexpected Cardiac Arrest	Number of patients with at least one cardiac arrest in intensive care with attempted cardiopulmonary resuscitation as a proportion of total admissions.	1 year
Secondary	Number of Patients Per Reason for ICU Admission	Number of patients admitted to ICU with either Medical (vs surgical) reason for admission, circulatory failure, respiratory failure, cardiac arrest, cardiac surgery	1 year
Secondary	History, Comorbidities Before Unexpected Cardiac Arrest	High blood pressure, Diabetes, Dyslipidemia, Tobacco, Ischemic heart disease, Heart disease from another cause, Malignancy, Alcohol, Renal disease, Respiratory disease, Cardiac arrest, Neurological disease, Liver disease	1 year
Secondary	Mc Cabe Score Before Unexpected Cardiac Arrest	0- absence of underlying disease or non-life-threatening disease; underlying life-threatening disease over a period of 5 years; underlying disease estimated fatal within 1 year	1 year
Secondary	Knaus Score Before Unexpected Cardiac Arrest	A- No activity limitation B- Moderate restriction of activity (limited professional activities) C- Major activity restriction but not total D- Major activity restriction, bedridden condition, long-term hospitalization	1 year
Secondary	Organ Failure Score Before Unexpected Cardiac Arrest	sequential organ failure assessment (SOFA) sub-score = 3; Respiratory failure: < 200 fraction of inspired oxygen inspired oxygen fraction (26.7 mmHg [kilopascal]) and mechanically ventilated,; Neurological impairment : Glasgow coma scale <10,; Circulatory failure: dopamine > 5 µg/kg/min OR epinephrine = 0.1 µg/kg/min OR norepinephrine = 0.1 µg/kg/min,; Hepatic failure: = 6.0-11.9 mg/dl [102-204 µmol/L] Bilirubin,; Haematological failure: < 50 Platelets×103/µl,; Renal failure: = 3.5-4.9 mg/dl [300-44 0µmol/L] (or < 500 ml/d) Creatinine	1 year
Secondary	Number of Participants With Unexpected Cardiac Arrest Etiologies		1 year
Secondary	Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation		1 year
Secondary	Cerebral Performance Category Scale at Hospital Discharge	Cerebral performance category score (CPC); Conscious without neurological deficit or minor deficit; Conscious with moderate deficit; Conscious with severe deficit; Deep Coma or Vegetative State; Deceased	at Hospital Discharge
Secondary	Cerebral Performance Category Scale at 6 Months	Cerebral performance category score (CPC); Conscious without neurological deficit or minor deficit; Conscious with moderate deficit; Conscious with severe deficit; Deep Coma or Vegetative State; Deceased	at 6 months after inclusion (unexpected cardiac arrest)
Secondary	Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate		1 year