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Unexpected Cardiac Arrest in Intensive Care Unit (ACIR)

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ClinicalTrials.gov Identifier: NCT03021564
Recruitment Status : Completed
First Posted : January 16, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier de la Rochelle Ré Aunis

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.

Condition or disease Intervention/treatment
Heart Arrest Other: cardiopulmonary resuscitation

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
Actual Enrollment : 677 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Etude Observationnelle Multicentrique Prospective Sur l'épidémiologie, Les Facteurs de Risques et Les conséquences Des Arrêts Cardiaques Inattendus Survenant en Réanimation
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR Cardiac Arrest


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


Primary Outcome Measures :
  1. Incidence of unexpected cardiac arrest [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of patients admitted to ICU with either Septic shock, Other shock, Respiratory distress, Renal pathology, Coma - Neurological disorders, Resuscitated cardiac arrest, or Other [ Time Frame: 1 year ]
  2. History, comorbidities before unexpected cardiac arrest [ Time Frame: 1 year ]
    Diabetes, Hypertension, Smoking, Dyslipidemia, Coronary artery disease, Chronic respiratory insufficiency, Chronic heart failure, Chronic renal insufficiency, Chronic hepatic insufficiency, Chronic neurological disease, Cancer, malignant hemopathy

  3. Mc Cabe score before unexpected cardiac arrest [ Time Frame: 1 year ]

    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

  4. 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

  5. Organ failure score before unexpected cardiac arrest [ Time Frame: 1 year ]
    Respiratory failure, Neurological impairment, Circulatory failure, Hepatic failure, Haematological failure, Renal failure

  6. unexpected cardiac arrest etiologies [ Time Frame: 1 year ]
  7. Number of patients with resumption of spontaneous cardiac activity after Cardiopulmonary resuscitation [ Time Frame: 1 year ]
  8. Glasgow score after resuscitation [ Time Frame: up to 5 days after resuscitation ]
    Evaluation of neurological prognosis after unexpected cardiac arrest

  9. Cerebral performance category scale at hospital discharge [ Time Frame: up to 6 months after unexpected cardiac arrest ]
    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

  10. Cerebral performance category scale at 6 months [ Time Frame: 6 months after unexpected cardiac arrest ]
    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

  11. Proportion of patients with unexpected cardiac arrest, not resuscitated, without having been the subject of a previous non-resuscitation decision [ Time Frame: 1 year ]
  12. Proportion of patients with unexpected cardiac arrest, resuscitated despite previous decision not to resuscitate [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021564


Locations
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
CHD Vendée
La Roche sur Yon, France
GH La Rochelle Ré Aunis
La Rochelle, France
CHU La Réunion
La Réunion, 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
CH Niort
Niort, France
CHU Nîmes
Nîmes, 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, France
Sponsors and Collaborators
Groupe Hospitalier de la Rochelle Ré Aunis
Investigators
Study Director: Maxime Leloup, MD Groupe Hospitalier de la Rochelle Ré Aunis

Publications:

Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
ClinicalTrials.gov Identifier: NCT03021564     History of Changes
Other Study ID Numbers: 2015/P04/049
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases