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Heart ArrestACIRNCT03021564

Unexpected Cardiac Arrest in Intensive Care Unit

An observational study of Heart Arrest, run by Groupe Hospitalier de la Rochelle Ré Aunis at 45 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Arrest
What is being tested?
cardiopulmonary resuscitation
Type of treatment
Injection or infusion
How many people
677 participants
Where
45 sitesFrance
Study dates
Jan 2017to Jun 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

France45 sites

  • CH Agen

    Agen

  • CHU Angers

    Angers

  • CH Angouleme

    Angoulême

  • CH Angoulême

    Angoulême

  • CH Arras

    Arras

  • GH Carnelle Portes de l'Oise

    Beaumont

  • CH Béthune

    Béthune

  • CH Blois

    Blois

  • APHP

    Bobigny

  • CH Bourg en Bresse

    Bourg-en-Bresse

  • CHU Brest

    Brest

  • CHU Caen

    Caen

  • CH Cahors

    Cahors

  • CH Chartres

    Chartres

  • CH Cholet

    Cholet

  • CH Colmar

    Colmar

  • CH Dieppe

    Dieppe

  • CHU Dijon

    Dijon

  • CH Sud Essonnes

    Étampes

  • APHP

    Garches

  • CHU Grenoble

    Grenoble

  • CH Gueret

    Guéret

  • CHU La Réunion

    La Réunion

  • CHD Vendée

    La Roche-sur-Yon

  • GH La Rochelle Ré Aunis

    La Rochelle

  • CH Lens

    Lens

  • GH de l'Institut Catholique de Lille

    Lille

  • CHU Limoges

    Limoges

  • CHU Lyon

    Lyon

  • CH Meaux

    Meaux

  • CH Melun

    Melun

  • CHU Nantes

    Nantes

  • CHU Nîmes

    Nîmes

  • CH Niort

    Niort

  • CHR Orleans

    Orléans

  • APHP Cochin

    Paris

  • APHP Saint Louis

    Paris

  • Hôpital Paris Saint Joseph

    Paris

  • CH Pau

    Pau

  • CHU Poitiers

    Poitiers

  • CH Pontoise

    Pontoise

  • CH Cornouaille

    Quimper

  • CH Roanne

    Roanne

  • CHU Rouen

    Rouen

  • CH Versailles

    Versailles

Other trials in France

About this study

Official title: 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.

Read the 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
Being tested
cardiopulmonary resuscitation
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cardiopulmonary resuscitationOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (10)

  1. 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

    Measured: 1 year

  2. 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

    Measured: 1 year

  3. Mc Cabe Score Before Unexpected Cardiac Arrest

    0- absence of underlying disease or non-life-threatening disease

    1. underlying life-threatening disease over a period of 5 years
    2. underlying disease estimated fatal within 1 year

    Measured: 1 year

  4. 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

    Measured: 1 year

  5. 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

    Measured: 1 year

  6. Number of Participants With Unexpected Cardiac Arrest Etiologies

    Measured: 1 year

  7. Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation

    Measured: 1 year

  8. Cerebral Performance Category Scale at Hospital Discharge

    Cerebral performance category score (CPC)

    1. Conscious without neurological deficit or minor deficit
    2. Conscious with moderate deficit
    3. Conscious with severe deficit
    4. Deep Coma or Vegetative State
    5. Deceased

    Measured: at Hospital Discharge

  9. Cerebral Performance Category Scale at 6 Months

    Cerebral performance category score (CPC)

    1. Conscious without neurological deficit or minor deficit
    2. Conscious with moderate deficit
    3. Conscious with severe deficit
    4. Deep Coma or Vegetative State
    5. Deceased

    Measured: at 6 months after inclusion (unexpected cardiac arrest)

  10. Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionDec 2017
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
677 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03021564
Sponsor's protocol ID
2015/P04/049
Acronym
ACIR
Status last verified
Jul 2020
First submitted
10 Jan 2017
Last updated
17 Aug 2020
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24326274

  • 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.

    PubMed 7261642

  • 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.

    PubMed 3416501

  • 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.

    PubMed 12668298

  • 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.

    PubMed 25091789

  • 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.

    PubMed 23550795

  • 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.

    PubMed 2060338

  • 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.

    PubMed 16989937

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

    PubMed 1444691

  • 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.

    PubMed 20413625

  • 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.

    PubMed 21844108

  • 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.

    PubMed 7719542

  • 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.

    PubMed 9133537

  • 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.

    PubMed 16129543

  • 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.

    PubMed 22227081

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Arrest, run by Groupe Hospitalier de la Rochelle Ré Aunis at 45 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Unexpected Cardiac Arrest (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03021564, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.

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