Trial Outcomes & Findings for Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients (NCT NCT02011568)

NCT ID: NCT02011568

Last Updated: 2024-12-06

Results Overview

The primary outcome of the study will be death or poor neurologic outcome at six months. Neurologic outcome will be assessed by a specialist in rehabilitation medicine using the Disability Ratings Scale (DRS. Patients will be judged to have had a poor neurologic outcome if the score on the DRS scale is \>5.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 389 participants
• Primary outcome timeframe: Six months
• Results posted on: 2024-12-06

Participant Flow

Patients with out-of-hospital cardiac arrest surviving to hospital admission and referred for post-cardiac arrest care were recruited.

Participant milestones

Measure	Moderate Hypothermia Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Overall Study STARTED	193	196
Overall Study COMPLETED	184	183
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Measure	Moderate Hypothermia Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Overall Study Withdrawal by Subject	8	10
Overall Study Physician Decision	1	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia	Total n=367 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 14.2 • n=184 Participants	61.7 years STANDARD_DEVIATION 13.3 • n=183 Participants	61.5 years STANDARD_DEVIATION 13.6 • n=367 Participants
Sex: Female, Male Female	32 Participants n=184 Participants	37 Participants n=183 Participants	69 Participants n=367 Participants
Sex: Female, Male Male	152 Participants n=184 Participants	146 Participants n=183 Participants	298 Participants n=367 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	184 participants n=184 Participants	183 participants n=183 Participants	367 participants n=367 Participants

PRIMARY outcome

Timeframe: Six months

The primary outcome of the study will be death or poor neurologic outcome at six months. Neurologic outcome will be assessed by a specialist in rehabilitation medicine using the Disability Ratings Scale (DRS. Patients will be judged to have had a poor neurologic outcome if the score on the DRS scale is >5.

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Participants With Death or Poor Neurologic Outcome at 6 Months	89 Participants	83 Participants

SECONDARY outcome

Timeframe: 30 days and 6 months

All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Mortality	80 Participants	75 Participants

SECONDARY outcome

Timeframe: 30 days and 6 months

Stroke will be classified as hemorrhagic versus non-hemorrhagic.

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Participants With Stroke 30 days	8 Participants	3 Participants
Number of Participants With Stroke 6 months	8 Participants	3 Participants

SECONDARY outcome

Timeframe: During index hospitalization, up to 40 days

Bleeding will be assessed using the TIMI definition and will be scored as major or minor.

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Participants With Bleeding	43 Participants	36 Participants

SECONDARY outcome

Timeframe: Admission to unit to discharge from unit

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Length of Stay in the Unit	10 days Interval 7.0 to 15.0	7 days Interval 6.0 to 12.0

SECONDARY outcome

Timeframe: Admission to hospital to discharge from hospital.

The length of stay participant was in hospital (day of admission to day of discharge from facility)

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Length of Stay in the Hospital	22 days Interval 16.0 to 30.0	20 days Interval 13.0 to 36.0

SECONDARY outcome

Timeframe: During index hospitalization - day of admission to day of discharge from the facility (*up to 30 days post admission)

The total number of participants who had cardiogenic shock during their admission (day of admission to day of discharge from facility)

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Participants With Cardiogenic Shock	71 Participants	61 Participants

SECONDARY outcome

Timeframe: Six months

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR)	20 Participants	17 Participants

SECONDARY outcome

Timeframe: During index hospitalization (*up to 45 days post admission day while in hospital)

Count of participants who had seizures while in hospital (day of admission to day of discharge from the facility)

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Participants With Seizures	23 Participants	13 Participants

SECONDARY outcome

Timeframe: During index hospitalization - day of admission up to 45 days post admission while in hospital

Participants who required renal replacement therapy (e.g. CRRT, IHD)

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Participants With Renal Failure Requiring Renal Replacement Therapy	23 Participants	13 Participants

SECONDARY outcome

Timeframe: During index hospitalization - from day of admission up to 45 days post admission (while in hospital)

The number of participants who developed ventilator associated pneumonia

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Participants With Ventilator Associated Pneumonia	124 Participants	116 Participants

SECONDARY outcome

Timeframe: Within 6 months of their admission

Participants who are diagnosed with stent thrombosis

Outcome measures

Measure	Moderate Hypothermia n=184 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Participants With Stent Thrombosis	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Six months

Population: Survivors discharged to home from hospital.

Outcome measures

Measure	Moderate Hypothermia n=103 Participants Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=107 Participants Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Number of Participants Discharged Home	93 Participants	99 Participants

Adverse Events

Moderate Hypothermia

Serious events: 28 serious events

Other events: 0 other events

Deaths: 80 deaths

Mild Hypothermia

Serious events: 34 serious events

Other events: 0 other events

Deaths: 75 deaths

Serious adverse events

Measure	Moderate Hypothermia n=184 participants at risk Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia	Mild Hypothermia n=183 participants at risk Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia
Blood and lymphatic system disorders Deep Vein Thrombosis	11.4% 21/184 • Number of events 21 • 180 days	10.9% 20/183 • Number of events 20 • 180 days
Blood and lymphatic system disorders Inferior Vena cava thrombosis	3.8% 7/184 • Number of events 7 • 180 days	7.7% 14/183 • Number of events 14 • 180 days

Other adverse events

Adverse event data not reported

Additional Information

Dr Michel Le May

University of Ottawa Heart Institute

Phone: 613-696-7000

Email: mlemay@ottawaheart.ca

Results disclosure agreements

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