- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03021564
Unexpected Cardiac Arrest in Intensive Care Unit (ACIR)
July 31, 2020 updated by: Groupe Hospitalier de la Rochelle Ré Aunis
Prospective Multi-centre Observational Study on the Epidemiology, Risk Factors and Consequences of Unexpected Cardiac Arrest in Intensive Care Units.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
677
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Agen, France
- CH Agen
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Angers, France
- CHU Angers
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Angouleme, France
- CH Angoulême
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Arras, France
- CH Arras
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Beaumont, France
- GH Carnelle Portes de l'Oise
-
Bethune, France
- CH Bethune
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Blois, France
- CH BLOIS
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Bobigny, France
- APHP
-
Bourg en Bresse, France
- CH Bourg en Bresse
-
Brest, France
- CHU Brest
-
Caen, France
- CHU Caen
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Cahors, France
- CH Cahors
-
Chartres, France
- CH Chartres
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Cholet, France
- Ch Cholet
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Colmar, France
- CH Colmar
-
Dieppe, France
- CH Dieppe
-
Dijon, France
- CHU Dijon
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Etampes, France
- CH Sud Essonnes
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Garches, France
- APHP
-
Grenoble, France
- CHU Grenoble
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Gueret, France
- CH Guéret
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La Roche sur Yon, France
- CHD Vendée
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La Rochelle, France
- GH La Rochelle Ré Aunis
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La Réunion, France
- CHU La Réunion
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Lens, France
- CH LENS
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Lille, France
- GH de l'Institut Catholique de Lille
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Limoges, France
- Chu Limoges
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Lyon, France
- CHU Lyon
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Meaux, France
- CH Meaux
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Melun, France
- CH Melun
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Nantes, France
- CHU Nantes
-
Niort, France
- CH Niort
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Nîmes, France
- CHU Nîmes
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Orleans, France
- CHR Orléans
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Paris, France
- Aphp Cochin
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Paris, France
- Hopital Paris Saint Joseph
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Paris, France
- APHP Saint Louis
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Pau, France
- CH Pau
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Poitiers, France
- CHU Poitiers
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Pontoise, France
- CH Pontoise
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Quimper, France
- Ch Cornouaille
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Roanne, France
- CH Roanne
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Rouen, France
- CHU Rouen
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Versailles, France
- CH Versailles
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Unexpected Cardiac Arrest
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Per Reason for ICU Admission
Time Frame: 1 year
|
Number of patients admitted to ICU with either Medical (vs surgical) reason for admission, circulatory failure, respiratory failure, cardiac arrest, cardiac surgery
|
1 year
|
History, Comorbidities Before Unexpected Cardiac Arrest
Time Frame: 1 year
|
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
|
Mc Cabe Score Before Unexpected Cardiac Arrest
Time Frame: 1 year
|
0- absence of underlying disease or non-life-threatening disease
|
1 year
|
Knaus Score Before Unexpected Cardiac Arrest
Time Frame: 1 year
|
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
|
Organ Failure Score Before Unexpected Cardiac Arrest
Time Frame: 1 year
|
sequential organ failure assessment (SOFA) sub-score ≥ 3
|
1 year
|
Number of Participants With Unexpected Cardiac Arrest Etiologies
Time Frame: 1 year
|
1 year
|
|
Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation
Time Frame: 1 year
|
1 year
|
|
Cerebral Performance Category Scale at Hospital Discharge
Time Frame: at Hospital Discharge
|
Cerebral performance category score (CPC)
|
at Hospital Discharge
|
Cerebral Performance Category Scale at 6 Months
Time Frame: at 6 months after inclusion (unexpected cardiac arrest)
|
Cerebral performance category score (CPC)
|
at 6 months after inclusion (unexpected cardiac arrest)
|
Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Maxime Leloup, MD, Groupe Hospitalier de la Rochelle Ré Aunis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Landry FJ, Parker JM, Phillips YY. Outcome of cardiopulmonary resuscitation in the intensive care setting. Arch Intern Med. 1992 Nov;152(11):2305-8.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
December 1, 2017
Study Completion (ACTUAL)
June 1, 2018
Study Registration Dates
First Submitted
January 10, 2017
First Submitted That Met QC Criteria
January 12, 2017
First Posted (ESTIMATE)
January 16, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 17, 2020
Last Update Submitted That Met QC Criteria
July 31, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/P04/049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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