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Unexpected Cardiac Arrest in Intensive Care Unit

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03021564
Acronym
ACIR
Enrollment
677
Registered
2017-01-16
Start date
2017-01-31
Completion date
2018-06-30
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Arrest

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.

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.

Interventions

OTHERcardiopulmonary resuscitation

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

Sponsors

Groupe Hospitalier de la Rochelle Ré Aunis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With Unexpected Cardiac Arrest1 yearNumber of patients with at least one cardiac arrest in intensive care with attempted cardiopulmonary resuscitation as a proportion of total admissions.

Secondary

MeasureTime frameDescription
History, Comorbidities Before Unexpected Cardiac Arrest1 yearHigh 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
Mc Cabe Score Before Unexpected Cardiac Arrest1 year0- 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
Knaus Score Before Unexpected Cardiac Arrest1 yearA- 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
Organ Failure Score Before Unexpected Cardiac Arrest1 yearsequential 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
Number of Patients Per Reason for ICU Admission1 yearNumber of patients admitted to ICU with either Medical (vs surgical) reason for admission, circulatory failure, respiratory failure, cardiac arrest, cardiac surgery
Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation1 year
Cerebral Performance Category Scale at Hospital Dischargeat Hospital DischargeCerebral 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
Cerebral Performance Category Scale at 6 Monthsat 6 months after inclusion (unexpected cardiac arrest)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
Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate1 year
Number of Participants With Unexpected Cardiac Arrest Etiologies1 year

Countries

France

Participant flow

Pre-assignment details

31,399 patients were admitted to intensive care unit (ICU), 24,245 were discharged alive without in-ICU cardiac arrest, 6,477 died in the ICU with no cardiopulmonary resuscitation (CPR) attempt, 677 had cardiac arrest with CPR attempt.

Participants by arm

ArmCount
Shockable Rhythms
Patients with documented shockable rhythms during cardiac arrest
120
Non-shockable Rhythms
Patients with documented non-shockable rhythms during cardiac arrest
557
Total677

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath84466
Overall StudyLost to Follow-up02

Baseline characteristics

CharacteristicNon-shockable RhythmsTotalShockable Rhythms
Age, Customized
Age
69 years69 years71 years
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
France
557 participants677 participants120 participants
Sex: Female, Male
Female
175 Participants210 Participants35 Participants
Sex: Female, Male
Male
382 Participants467 Participants85 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
550 / 677
other
Total, other adverse events
118 / 677
serious
Total, serious adverse events
7 / 677

Outcome results

Primary

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.

Time frame: 1 year

Population: Screening of all inpatients in the ICU during the study period. Only in-ICU cardiac arrest with attempted CPR are included in the study

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsNumber of Patients With Unexpected Cardiac Arrestin-ICU cardiac arrest with attempted CPR677 Participants
In-ICU AdmissionsNumber of Patients With Unexpected Cardiac ArrestNo attempted CPR30,722 Participants
Secondary

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

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsCerebral Performance Category Scale at 6 MonthsCPC 1 or 236 Participants
In-ICU AdmissionsCerebral Performance Category Scale at 6 MonthsCPC 30 Participants
In-ICU AdmissionsCerebral Performance Category Scale at 6 MonthsCPC 40 Participants
Non-shockable RhythmsCerebral Performance Category Scale at 6 MonthsCPC 1 or 282 Participants
Non-shockable RhythmsCerebral Performance Category Scale at 6 MonthsCPC 36 Participants
Non-shockable RhythmsCerebral Performance Category Scale at 6 MonthsCPC 41 Participants
Secondary

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

Time frame: at Hospital Discharge

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsCerebral Performance Category Scale at Hospital DischargeCPC 1 or 243 Participants
In-ICU AdmissionsCerebral Performance Category Scale at Hospital DischargeCPC 31 Participants
In-ICU AdmissionsCerebral Performance Category Scale at Hospital DischargeCPC 40 Participants
Non-shockable RhythmsCerebral Performance Category Scale at Hospital DischargeCPC 1 or 292 Participants
Non-shockable RhythmsCerebral Performance Category Scale at Hospital DischargeCPC 38 Participants
Non-shockable RhythmsCerebral Performance Category Scale at Hospital DischargeCPC 42 Participants
Secondary

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

Time frame: 1 year

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestDyslipidemia47 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestAlcohol18 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestIschemic heart disease52 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestRenal disease18 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestDiabetes37 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestRespiratory disease15 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestHeart disease from another cause35 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestCardiac arrest8 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestTobacco37 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestNeurological disease7 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestMalignancy18 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestLiver disease5 Participants
In-ICU AdmissionsHistory, Comorbidities Before Unexpected Cardiac ArrestHigh blood pressure75 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestLiver disease18 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestHigh blood pressure322 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestDiabetes182 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestDyslipidemia156 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestTobacco164 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestIschemic heart disease137 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestHeart disease from another cause106 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestMalignancy153 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestAlcohol105 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestRenal disease105 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestRespiratory disease103 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestCardiac arrest41 Participants
Non-shockable RhythmsHistory, Comorbidities Before Unexpected Cardiac ArrestNeurological disease31 Participants
Secondary

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

Time frame: 1 year

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsKnaus Score Before Unexpected Cardiac ArrestKnaus A or B (no or moderate limitation)92 Participants
In-ICU AdmissionsKnaus Score Before Unexpected Cardiac ArrestKnaus C or D28 Participants
Non-shockable RhythmsKnaus Score Before Unexpected Cardiac ArrestKnaus C or D165 Participants
Non-shockable RhythmsKnaus Score Before Unexpected Cardiac ArrestKnaus A or B (no or moderate limitation)392 Participants
Secondary

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

Time frame: 1 year

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsMc Cabe Score Before Unexpected Cardiac ArrestMcCabe 0 (no fatal disease)63 Participants
In-ICU AdmissionsMc Cabe Score Before Unexpected Cardiac ArrestMcCabe 1 or 257 Participants
Non-shockable RhythmsMc Cabe Score Before Unexpected Cardiac ArrestMcCabe 0 (no fatal disease)269 Participants
Non-shockable RhythmsMc Cabe Score Before Unexpected Cardiac ArrestMcCabe 1 or 2288 Participants
Secondary

Number of Participants With Unexpected Cardiac Arrest Etiologies

Time frame: 1 year

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsNumber of Participants With Unexpected Cardiac Arrest EtiologiesAt least one cause ultimately identified91 Participants
In-ICU AdmissionsNumber of Participants With Unexpected Cardiac Arrest EtiologiesHypovolemia11 Participants
In-ICU AdmissionsNumber of Participants With Unexpected Cardiac Arrest EtiologiesAttributed to the life-sustaining device(s)11 Participants
In-ICU AdmissionsNumber of Participants With Unexpected Cardiac Arrest EtiologiesHypoxia15 Participants
In-ICU AdmissionsNumber of Participants With Unexpected Cardiac Arrest EtiologiesRespiratory support1 Participants
In-ICU AdmissionsNumber of Participants With Unexpected Cardiac Arrest EtiologiesMetabolic disorder30 Participants
In-ICU AdmissionsNumber of Participants With Unexpected Cardiac Arrest EtiologiesCirculatory assistance7 Participants
In-ICU AdmissionsNumber of Participants With Unexpected Cardiac Arrest EtiologiesMedications3 Participants
Non-shockable RhythmsNumber of Participants With Unexpected Cardiac Arrest EtiologiesCirculatory assistance32 Participants
Non-shockable RhythmsNumber of Participants With Unexpected Cardiac Arrest EtiologiesMedications19 Participants
Non-shockable RhythmsNumber of Participants With Unexpected Cardiac Arrest EtiologiesHypovolemia83 Participants
Non-shockable RhythmsNumber of Participants With Unexpected Cardiac Arrest EtiologiesHypoxia164 Participants
Non-shockable RhythmsNumber of Participants With Unexpected Cardiac Arrest EtiologiesAt least one cause ultimately identified445 Participants
Non-shockable RhythmsNumber of Participants With Unexpected Cardiac Arrest EtiologiesMetabolic disorder92 Participants
Non-shockable RhythmsNumber of Participants With Unexpected Cardiac Arrest EtiologiesAttributed to the life-sustaining device(s)87 Participants
Non-shockable RhythmsNumber of Participants With Unexpected Cardiac Arrest EtiologiesRespiratory support39 Participants
Secondary

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

Time frame: 1 year

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsNumber of Patients Per Reason for ICU AdmissionCardiac surgery2 Participants
In-ICU AdmissionsNumber of Patients Per Reason for ICU AdmissionMedical (vs surgical) reason for admission100 Participants
In-ICU AdmissionsNumber of Patients Per Reason for ICU AdmissionCirculatory failure37 Participants
In-ICU AdmissionsNumber of Patients Per Reason for ICU AdmissionRespiratory failure22 Participants
In-ICU AdmissionsNumber of Patients Per Reason for ICU AdmissionCardiac arrest31 Participants
Non-shockable RhythmsNumber of Patients Per Reason for ICU AdmissionCardiac arrest69 Participants
Non-shockable RhythmsNumber of Patients Per Reason for ICU AdmissionRespiratory failure149 Participants
Non-shockable RhythmsNumber of Patients Per Reason for ICU AdmissionMedical (vs surgical) reason for admission487 Participants
Non-shockable RhythmsNumber of Patients Per Reason for ICU AdmissionCardiac surgery20 Participants
Non-shockable RhythmsNumber of Patients Per Reason for ICU AdmissionCirculatory failure210 Participants
Secondary

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

Time frame: 1 year

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsNumber of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitationreturn of spontaneous circulation ≥ 20 min97 Participants
In-ICU AdmissionsNumber of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitationreturn of spontaneous circulation ≥ 24 h73 Participants
Non-shockable RhythmsNumber of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitationreturn of spontaneous circulation ≥ 20 min381 Participants
Non-shockable RhythmsNumber of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitationreturn of spontaneous circulation ≥ 24 h223 Participants
Secondary

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

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsNumber of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate2 Participants
Non-shockable RhythmsNumber of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate11 Participants
Secondary

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

Time frame: 1 year

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
In-ICU AdmissionsOrgan Failure Score Before Unexpected Cardiac ArrestNeurological impairment48 Participants
In-ICU AdmissionsOrgan Failure Score Before Unexpected Cardiac ArrestCirculatory failure68 Participants
In-ICU AdmissionsOrgan Failure Score Before Unexpected Cardiac ArrestHepatic failure26 Participants
In-ICU AdmissionsOrgan Failure Score Before Unexpected Cardiac ArrestHaematological failure3 Participants
In-ICU AdmissionsOrgan Failure Score Before Unexpected Cardiac ArrestRespiratory failure42 Participants
In-ICU AdmissionsOrgan Failure Score Before Unexpected Cardiac ArrestRenal failure2 Participants
Non-shockable RhythmsOrgan Failure Score Before Unexpected Cardiac ArrestHaematological failure63 Participants
Non-shockable RhythmsOrgan Failure Score Before Unexpected Cardiac ArrestNeurological impairment177 Participants
Non-shockable RhythmsOrgan Failure Score Before Unexpected Cardiac ArrestRenal failure25 Participants
Non-shockable RhythmsOrgan Failure Score Before Unexpected Cardiac ArrestCirculatory failure269 Participants
Non-shockable RhythmsOrgan Failure Score Before Unexpected Cardiac ArrestRespiratory failure195 Participants
Non-shockable RhythmsOrgan Failure Score Before Unexpected Cardiac ArrestHepatic failure168 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026