Trial Outcomes & Findings for Unexpected Cardiac Arrest in Intensive Care Unit (NCT NCT03021564)

NCT ID: NCT03021564

Last Updated: 2020-08-17

Results Overview

Number of patients with at least one cardiac arrest in intensive care with attempted cardiopulmonary resuscitation as a proportion of total admissions.

• Recruitment status: COMPLETED
• Target enrollment: 677 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2020-08-17

Participant Flow

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.

Participant milestones

Measure	Shockable Rhythms Patients with documented shockable rhythms during cardiac arrest	Non-shockable Rhythms Patients with documented non-shockable rhythms during cardiac arrest
Overall Study STARTED	120	557
Overall Study COMPLETED	36	89
Overall Study NOT COMPLETED	84	468

Reasons for withdrawal

Measure	Shockable Rhythms Patients with documented shockable rhythms during cardiac arrest	Non-shockable Rhythms Patients with documented non-shockable rhythms during cardiac arrest
Overall Study Death	84	466
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Shockable Rhythms n=120 Participants Patients with documented shockable rhythms during cardiac arrest	Non-shockable Rhythms n=557 Participants Patients with documented non-shockable rhythms during cardiac arrest	Total n=677 Participants Total of all reporting groups
Age, Customized Age	71 years n=120 Participants	69 years n=557 Participants	69 years n=677 Participants
Sex: Female, Male Female	35 Participants n=120 Participants	175 Participants n=557 Participants	210 Participants n=677 Participants
Sex: Female, Male Male	85 Participants n=120 Participants	382 Participants n=557 Participants	467 Participants n=677 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	120 participants n=120 Participants	557 participants n=557 Participants	677 participants n=677 Participants

PRIMARY outcome

Timeframe: 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

Number of patients with at least one cardiac arrest in intensive care with attempted cardiopulmonary resuscitation as a proportion of total admissions.

Outcome measures

Measure	In-ICU Admissions n=31 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms Patients with documented non-shockable rhythms during cardiac arrest
Number of Patients With Unexpected Cardiac Arrest in-ICU cardiac arrest with attempted CPR	677 Participants	—
Number of Patients With Unexpected Cardiac Arrest No attempted CPR	30,722 Participants	—

SECONDARY outcome

Timeframe: 1 year

Number of patients admitted to ICU with either Medical (vs surgical) reason for admission, circulatory failure, respiratory failure, cardiac arrest, cardiac surgery

Outcome measures

Measure	In-ICU Admissions n=120 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms n=557 Participants Patients with documented non-shockable rhythms during cardiac arrest
Number of Patients Per Reason for ICU Admission Medical (vs surgical) reason for admission	100 Participants	487 Participants
Number of Patients Per Reason for ICU Admission Circulatory failure	37 Participants	210 Participants
Number of Patients Per Reason for ICU Admission Respiratory failure	22 Participants	149 Participants
Number of Patients Per Reason for ICU Admission Cardiac arrest	31 Participants	69 Participants
Number of Patients Per Reason for ICU Admission Cardiac surgery	2 Participants	20 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	In-ICU Admissions n=120 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms n=557 Participants Patients with documented non-shockable rhythms during cardiac arrest
History, Comorbidities Before Unexpected Cardiac Arrest High blood pressure	75 Participants	322 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Diabetes	37 Participants	182 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Dyslipidemia	47 Participants	156 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Tobacco	37 Participants	164 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Ischemic heart disease	52 Participants	137 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Heart disease from another cause	35 Participants	106 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Malignancy	18 Participants	153 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Alcohol	18 Participants	105 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Renal disease	18 Participants	105 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Respiratory disease	15 Participants	103 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Cardiac arrest	8 Participants	41 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Neurological disease	7 Participants	31 Participants
History, Comorbidities Before Unexpected Cardiac Arrest Liver disease	5 Participants	18 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	In-ICU Admissions n=120 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms n=557 Participants Patients with documented non-shockable rhythms during cardiac arrest
Mc Cabe Score Before Unexpected Cardiac Arrest McCabe 0 (no fatal disease)	63 Participants	269 Participants
Mc Cabe Score Before Unexpected Cardiac Arrest McCabe 1 or 2	57 Participants	288 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	In-ICU Admissions n=120 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms n=557 Participants Patients with documented non-shockable rhythms during cardiac arrest
Knaus Score Before Unexpected Cardiac Arrest Knaus A or B (no or moderate limitation)	92 Participants	392 Participants
Knaus Score Before Unexpected Cardiac Arrest Knaus C or D	28 Participants	165 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	In-ICU Admissions n=120 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms n=557 Participants Patients with documented non-shockable rhythms during cardiac arrest
Organ Failure Score Before Unexpected Cardiac Arrest Respiratory failure	42 Participants	195 Participants
Organ Failure Score Before Unexpected Cardiac Arrest Neurological impairment	48 Participants	177 Participants
Organ Failure Score Before Unexpected Cardiac Arrest Circulatory failure	68 Participants	269 Participants
Organ Failure Score Before Unexpected Cardiac Arrest Hepatic failure	26 Participants	168 Participants
Organ Failure Score Before Unexpected Cardiac Arrest Haematological failure	3 Participants	63 Participants
Organ Failure Score Before Unexpected Cardiac Arrest Renal failure	2 Participants	25 Participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	In-ICU Admissions n=120 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms n=557 Participants Patients with documented non-shockable rhythms during cardiac arrest
Number of Participants With Unexpected Cardiac Arrest Etiologies At least one cause ultimately identified	91 Participants	445 Participants
Number of Participants With Unexpected Cardiac Arrest Etiologies Hypoxia	15 Participants	164 Participants
Number of Participants With Unexpected Cardiac Arrest Etiologies Metabolic disorder	30 Participants	92 Participants
Number of Participants With Unexpected Cardiac Arrest Etiologies Hypovolemia	11 Participants	83 Participants
Number of Participants With Unexpected Cardiac Arrest Etiologies Attributed to the life-sustaining device(s)	11 Participants	87 Participants
Number of Participants With Unexpected Cardiac Arrest Etiologies Respiratory support	1 Participants	39 Participants
Number of Participants With Unexpected Cardiac Arrest Etiologies Circulatory assistance	7 Participants	32 Participants
Number of Participants With Unexpected Cardiac Arrest Etiologies Medications	3 Participants	19 Participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	In-ICU Admissions n=120 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms n=557 Participants Patients with documented non-shockable rhythms during cardiac arrest
Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation return of spontaneous circulation ≥ 20 min	97 Participants	381 Participants
Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation return of spontaneous circulation ≥ 24 h	73 Participants	223 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	In-ICU Admissions n=44 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms n=102 Participants Patients with documented non-shockable rhythms during cardiac arrest
Cerebral Performance Category Scale at Hospital Discharge CPC 1 or 2	43 Participants	92 Participants
Cerebral Performance Category Scale at Hospital Discharge CPC 3	1 Participants	8 Participants
Cerebral Performance Category Scale at Hospital Discharge CPC 4	0 Participants	2 Participants

SECONDARY outcome

Timeframe: at 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

Outcome measures

Measure	In-ICU Admissions n=36 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms n=89 Participants Patients with documented non-shockable rhythms during cardiac arrest
Cerebral Performance Category Scale at 6 Months CPC 1 or 2	36 Participants	82 Participants
Cerebral Performance Category Scale at 6 Months CPC 3	0 Participants	6 Participants
Cerebral Performance Category Scale at 6 Months CPC 4	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	In-ICU Admissions n=120 Participants Patients admitted in 45 participating intensive care unit (ICU) over one year	Non-shockable Rhythms n=557 Participants Patients with documented non-shockable rhythms during cardiac arrest
Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate	2 Participants	11 Participants

Adverse Events

In-ICU Admissions

Serious events: 7 serious events

Other events: 118 other events

Deaths: 550 deaths

Serious adverse events

Measure	In-ICU Admissions n=677 participants at risk Patients admitted in 45 participating intensive care unit (ICU) over one year
Nervous system disorders Conscious with severe deficit	1.0% 7/677 • Number of events 20 • 6-month follow up

Other adverse events

Measure	In-ICU Admissions n=677 participants at risk Patients admitted in 45 participating intensive care unit (ICU) over one year
Nervous system disorders Conscious without neurological deficit, minor or moderate deficit	17.4% 118/677 • Number of events 143 • 6-month follow up

Additional Information

Dr Maxime Leloup

Groupe Hospitalier de la Rochelle Ré Aunis

Phone: +33 (0)5 46 45 66 09

Email: maxime.leloup@ght-atlantique17.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place