N/A
Completed N=389
Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients
Source: ClinicalTrials.gov NCT02011568 ↗Enrolled (actual)
389
Serious AEs
16.9%
Results posted
Dec 2024
Primary outcomePrimary: Number of Participants With Death or Poor Neurologic Outcome at 6 Months — 89; 83 Participants
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.
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 | — |
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.
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. Informational only — not medical advice.