N/A N=389 Randomized Double-blind Treatment

Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients

Cardiac Arrest

Bottom Line

View on ClinicalTrials.gov: NCT02011568 ↗

Enrolled (actual)

389

Serious AEs

16.9%

Results posted

Dec 2024

Primary outcome: Primary: Number of Participants With Death or Poor Neurologic Outcome at 6 Months — 89; 83 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Therapeutic Hypothermia (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ottawa Heart Institute Research Corporation
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Death or Poor Neurologic Outcome at 6 Months	89; 83	—
SECONDARY Number of Mortality	80; 75	—
SECONDARY Number of Participants With Stroke	8; 3; 8; 3	—
SECONDARY Number of Participants With Bleeding	43; 36	—
SECONDARY Length of Stay in the Unit	10; 7	—
SECONDARY Length of Stay in the Hospital	22; 20	—
SECONDARY Number of Participants With Cardiogenic Shock	71; 61	—
SECONDARY Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR)	20; 17	—
SECONDARY Number of Participants With Seizures	23; 13	—
SECONDARY Number of Participants With Renal Failure Requiring Renal Replacement Therapy	23; 13	—
SECONDARY Number of Participants With Ventilator Associated Pneumonia	124; 116	—
SECONDARY Number of Participants With Stent Thrombosis	2; 4	—
SECONDARY Number of Participants Discharged Home	93; 99	—

Summary

This trial is currently a single-center, randomized, double-blind investigator initiated prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI). The plan is to expand the trial shortly as a multi-center project. The patients for this study will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (OHCA). The aim of this study is to determine whether neurologic outcomes at six months are improved with moderate (31 degrees Celsius) versus mild (34 degrees Celsius) therapeutic hypothermia (TH) following return of spontaneous circulation (ROSC) in patients suffering OHCA, with ROSC defined as the resumption of sustained perfusing cardiac activity. The primary outcome will be the proportion of patients experiencing death or a poor neurologic outcome at six months after out of hospital cardiac arrest.

Eligibility Criteria

Inclusion Criteria

Out of hospital cardiac arrest patient
Return of spontaneous circulation
Glasgow Coma Score equal or lesser than 8.

Exclusion Criteria

Patients residing in a Nursing Home or patients unable to reside independently,
Intracranial bleed responsible for the cardiac arrest,
Severe coagulopathy with clinical evidence of major bleeding,
Coma that is not attributable to cardiac arrest,
Pregnancy,
Life expectancy of 2.0, platelets <100,000 / mm3),
Participation in a study with another investigational device or drug < four weeks,
The Endovascular cooling (ZOLL) device is not available.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02011568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.