Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate hypothermia | Other | Therapeutic hypothermia at 31 degrees celsius |
|
| Mild Hypothermia | Active Comparator | Therapeutic Hypothermia at 34 degrees Celsius |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Hypothermia | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Death or Poor Neurologic Outcome at 6 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. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Mortality | All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac. | 30 days and 6 months |
| Number of Participants With Stroke | Stroke will be classified as hemorrhagic versus non-hemorrhagic. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michel R Le May, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | k1y 4w7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34665203 | Derived | Le May M, Osborne C, Russo J, So D, Chong AY, Dick A, Froeschl M, Glover C, Hibbert B, Marquis JF, De Roock S, Labinaz M, Bernick J, Marshall S, Maze R, Wells G. Effect of Moderate vs Mild Therapeutic Hypothermia on Mortality and Neurologic Outcomes in Comatose Survivors of Out-of-Hospital Cardiac Arrest: The CAPITAL CHILL Randomized Clinical Trial. JAMA. 2021 Oct 19;326(15):1494-1503. doi: 10.1001/jama.2021.15703. |
Not provided
Not provided
Not provided
Patients with out-of-hospital cardiac arrest surviving to hospital admission and referred for post-cardiac arrest care were recruited.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Hypothermia | Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia |
| FG001 | Mild Hypothermia | Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Hypothermia | Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia |
| BG001 | Mild Hypothermia | Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Death or Poor Neurologic Outcome at 6 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. | Posted | Count of Participants | Participants | Six months |
|
180 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate Hypothermia | Therapeutic hypothermia at 31 degrees celsius Therapeutic Hypothermia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michel Le May | University of Ottawa Heart Institute | 613-696-7000 | 14646 | mlemay@ottawaheart.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2013 | Jun 3, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 days and 6 months |
| Number of Participants With Bleeding | Bleeding will be assessed using the TIMI definition and will be scored as major or minor. | During index hospitalization, up to 40 days |
| Length of Stay in the Unit | Admission to unit to discharge from unit |
| Length of Stay in the Hospital | The length of stay participant was in hospital (day of admission to day of discharge from facility) | Admission to hospital to discharge from hospital. |
| Number of Participants With Cardiogenic Shock | The total number of participants who had cardiogenic shock during their admission (day of admission to day of discharge from facility) | During index hospitalization - day of admission to day of discharge from the facility (*up to 30 days post admission) |
| Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR) | Six months |
| Number of Participants With Seizures | Count of participants who had seizures while in hospital (day of admission to day of discharge from the facility) | During index hospitalization (*up to 45 days post admission day while in hospital) |
| Number of Participants With Renal Failure Requiring Renal Replacement Therapy | Participants who required renal replacement therapy (e.g. CRRT, IHD) | During index hospitalization - day of admission up to 45 days post admission while in hospital |
| Number of Participants With Ventilator Associated Pneumonia | The number of participants who developed ventilator associated pneumonia | During index hospitalization - from day of admission up to 45 days post admission (while in hospital) |
| Number of Participants With Stent Thrombosis | Participants who are diagnosed with stent thrombosis | Within 6 months of their admission |
| Number of Participants Discharged Home | Six months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Mortality | All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac. | Posted | Count of Participants | Participants | 30 days and 6 months |
|
|
|
| Secondary | Number of Participants With Stroke | Stroke will be classified as hemorrhagic versus non-hemorrhagic. | Posted | Count of Participants | Participants | 30 days and 6 months |
|
|
|
| Secondary | Number of Participants With Bleeding | Bleeding will be assessed using the TIMI definition and will be scored as major or minor. | Posted | Count of Participants | Participants | During index hospitalization, up to 40 days |
|
|
|
| Secondary | Length of Stay in the Unit | Posted | Median | Inter-Quartile Range | days | Admission to unit to discharge from unit |
|
|
|
| Secondary | Length of Stay in the Hospital | The length of stay participant was in hospital (day of admission to day of discharge from facility) | Posted | Median | Inter-Quartile Range | days | Admission to hospital to discharge from hospital. |
|
|
|
| Secondary | Number of Participants With Cardiogenic Shock | The total number of participants who had cardiogenic shock during their admission (day of admission to day of discharge from facility) | Posted | Count of Participants | Participants | During index hospitalization - day of admission to day of discharge from the facility (*up to 30 days post admission) |
|
|
|
| Secondary | Number of Participants With Repeat Circulatory Arrest Requiring Cardiopulmonary Resuscitation (CPR) | Posted | Count of Participants | Participants | Six months |
|
|
|
| Secondary | Number of Participants With Seizures | Count of participants who had seizures while in hospital (day of admission to day of discharge from the facility) | Posted | Count of Participants | Participants | During index hospitalization (*up to 45 days post admission day while in hospital) |
|
|
|
| Secondary | Number of Participants With Renal Failure Requiring Renal Replacement Therapy | Participants who required renal replacement therapy (e.g. CRRT, IHD) | Posted | Count of Participants | Participants | During index hospitalization - day of admission up to 45 days post admission while in hospital |
|
|
|
| Secondary | Number of Participants With Ventilator Associated Pneumonia | The number of participants who developed ventilator associated pneumonia | Posted | Count of Participants | Participants | During index hospitalization - from day of admission up to 45 days post admission (while in hospital) |
|
|
|
| Secondary | Number of Participants With Stent Thrombosis | Participants who are diagnosed with stent thrombosis | Posted | Count of Participants | Participants | Within 6 months of their admission |
|
|
|
| Secondary | Number of Participants Discharged Home | Survivors discharged to home from hospital. | Posted | Count of Participants | Participants | Six months |
|
|
|
| 80 |
| 184 |
| 28 |
| 184 |
| 0 |
| 184 |
| EG001 | Mild Hypothermia | Therapeutic Hypothermia at 34 degrees Celsius Therapeutic Hypothermia | 75 | 183 | 34 | 183 | 0 | 183 |
| Inferior Vena cava thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided