NCT03021564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
677

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

45 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 17, 2020

Completed
Last Updated

August 17, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

January 10, 2017

Results QC Date

July 7, 2020

Last Update Submit

July 31, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Number of Patients Per Reason for ICU Admission

    1 year

  • History, Comorbidities Before Unexpected Cardiac Arrest

    1 year

  • Mc Cabe Score Before Unexpected Cardiac Arrest

    1 year

  • Knaus Score Before Unexpected Cardiac Arrest

    1 year

  • Organ Failure Score Before Unexpected Cardiac Arrest

    1 year

  • +5 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted in intensive care unit during the study period and presenting an unexpected cardiac arrest will be included

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

CH Agen

Agen, France

Location

CHU Angers

Angers, France

Location

CH Angouleme

Angoulême, France

Location

CH Angoulême

Angoulême, France

Location

CH Arras

Arras, France

Location

GH Carnelle Portes de l'Oise

Beaumont, France

Location

CH Béthune

Béthune, France

Location

CH Blois

Blois, France

Location

APHP

Bobigny, France

Location

CH Bourg en Bresse

Bourg-en-Bresse, France

Location

CHU Brest

Brest, France

Location

CHU Caen

Caen, France

Location

CH Cahors

Cahors, France

Location

CH Chartres

Chartres, France

Location

CH Cholet

Cholet, France

Location

CH Colmar

Colmar, France

Location

CH Dieppe

Dieppe, France

Location

CHU Dijon

Dijon, France

Location

CH Sud Essonnes

Étampes, France

Location

APHP

Garches, France

Location

CHU Grenoble

Grenoble, France

Location

CH Gueret

Guéret, France

Location

CHU La Réunion

La Réunion, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

GH La Rochelle Ré Aunis

La Rochelle, France

Location

CH Lens

Lens, France

Location

GH de l'Institut Catholique de Lille

Lille, France

Location

CHU Limoges

Limoges, France

Location

CHU Lyon

Lyon, France

Location

CH Meaux

Meaux, France

Location

CH Melun

Melun, France

Location

CHU Nantes

Nantes, France

Location

CH Niort

Niort, France

Location

CHU Nîmes

Nîmes, France

Location

CHR Orleans

Orléans, France

Location

APHP Cochin

Paris, France

Location

APHP Saint Louis

Paris, France

Location

Hôpital Paris Saint Joseph

Paris, France

Location

CH Pau

Pau, France

Location

CHU Poitiers

Poitiers, France

Location

CH Pontoise

Pontoise, France

Location

CH Cornouaille

Quimper, France

Location

CH Roanne

Roanne, France

Location

CHU Rouen

Rouen, France

Location

CH Versailles

Versailles, France

Location

Related Publications (20)

  • 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.

    PMID: 24326274BACKGROUND
  • 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.

    PMID: 7261642BACKGROUND
  • 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.

    PMID: 3416501BACKGROUND
  • 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.

    PMID: 12668298BACKGROUND
  • 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.

    PMID: 25091789BACKGROUND
  • 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.

    PMID: 23550795BACKGROUND
  • 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.

    PMID: 2060338BACKGROUND
  • 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.

    PMID: 16989937BACKGROUND
  • Landry FJ, Parker JM, Phillips YY. Outcome of cardiopulmonary resuscitation in the intensive care setting. Arch Intern Med. 1992 Nov;152(11):2305-8.

    PMID: 1444691BACKGROUND
  • 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.

    PMID: 20413625BACKGROUND
  • 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.

    PMID: 21844108BACKGROUND
  • 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.

    PMID: 7719542BACKGROUND
  • 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.

    PMID: 9133537BACKGROUND
  • 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.

    PMID: 16129543BACKGROUND
  • 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.

    PMID: 22227081BACKGROUND
  • 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.

    PMID: 22281225BACKGROUND
  • 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.

    PMID: 25387815BACKGROUND
  • 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.

    PMID: 8844239BACKGROUND
  • 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.

    PMID: 26092498BACKGROUND
  • 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.

MeSH Terms

Conditions

Heart Arrest

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ResuscitationEmergency TreatmentTherapeutics

Results Point of Contact

Title
Dr Maxime Leloup
Organization
Groupe Hospitalier de la Rochelle Ré Aunis

Study Officials

  • Maxime Leloup, MD

    Groupe Hospitalier de la Rochelle Ré Aunis

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 16, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

August 17, 2020

Results First Posted

August 17, 2020

Record last verified: 2020-07

Locations