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NCT Number: NCT03021564

Unexpected Cardiac Arrest in Intensive Care Unit

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.

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Key information

Conditions

Heart Arrest Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Agen, Agen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiopulmonary resuscitation

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Mc Cabe Score Before Unexpected Cardiac Arrest

    Time frame: 1 year

    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

  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

    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

  6. Number of Participants With 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. Cerebral Performance Category Scale at Hospital Discharge

    Time frame: 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

  9. Cerebral Performance Category Scale at 6 Months

    Time frame: at 6 months after inclusion (unexpected cardiac arrest)

    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

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Registry information

Official study title

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

Acronym: ACIR

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 16, 2017
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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