Cardiac ArrestCAPITALCHILLNCT02011568
Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients
A study testing Therapeutic Hypothermia in people with Cardiac Arrest, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Therapeutic Hypothermia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out of hospital cardiac arrest patient
- Return of spontaneous circulation
- Glasgow Coma Score equal or lesser than 8.
Who cannot join
- 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 < one year due to any cause unrelated to the cardiac arrest,
Show all 9Show fewer
- Known coagulation disorder (i.e. INR >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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)
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.
- Conditions
- Cardiac Arrest
- Being tested
- Therapeutic Hypothermia
- Keywords
- Therapeutic Hypothermia, Out of hospital cardiac arrest, Mild hypothermia, Moderate hypothermia
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic HypothermiaOther
| Study group | Role | What they receive |
|---|---|---|
| Moderate hypothermia | Other | Therapeutic hypothermia at 31 degrees celsius Receives: Other: Therapeutic Hypothermia |
| Mild Hypothermia | Active comparator | Therapeutic Hypothermia at 34 degrees Celsius Receives: Other: Therapeutic Hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (12)
Number of Mortality
All cause mortality will be recorded. Mortality will be adjudicated as cardiac versus non-cardiac.
Measured: 30 days and 6 months
Number of Participants With Stroke
Stroke will be classified as hemorrhagic versus non-hemorrhagic.
Measured: 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.
Measured: During index hospitalization, up to 40 days
Length of Stay in the Unit
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Within 6 months of their admission
Number of Participants Discharged Home
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel R Le May, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011568
- Sponsor's protocol ID
- 2013106-01
- Acronym
- CAPITALCHILL
- Status last verified
- Oct 2023
- First submitted
- 8 Nov 2013
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34665203
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Hypothermia Following Out-of-Hospital Cardiac Arrest - A Randomized Trial Comparing Mild and Moderate Therapeutic Hypothermia (CAPITAL CHILL)
- ClinicalTrials.gov ID
- NCT02011568
- Acronym / sponsor ID
- CAPITALCHILL / 2013106-01
- Conditions
- Cardiac Arrest
- Keywords
- Therapeutic Hypothermia, Out of hospital cardiac arrest, Mild hypothermia, Moderate hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate hypothermia | Other | Other: Therapeutic HypothermiaTherapeutic hypothermia at 31 degrees celsius |
| Mild Hypothermia | Active comparator | Other: Therapeutic HypothermiaTherapeutic Hypothermia at 34 degrees Celsius |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Out of hospital cardiac arrest patient
- Return of spontaneous circulation
- Glasgow Coma Score equal or lesser than 8.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Hypothermia | Other | Mild Hypothermia, Moderate hypothermia |
Primary outcome
Number of Participants With Death or Poor Neurologic Outcome at 6 Months
Time frame: 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.
12 secondary outcomes
Number of Mortality
Time frame: 30 days and 6 months
Number of Participants With Stroke
Time frame: 30 days and 6 months
Number of Participants With Bleeding
Time frame: During index hospitalization, up to 40 days
Length of Stay in the Unit
Time frame: Admission to unit to discharge from unit
Length of Stay in the Hospital
Time frame: Admission to hospital to discharge from hospital.
Number of Participants With Cardiogenic Shock
Time frame: 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)
Time frame: Six months
Number of Participants With Seizures
Time frame: During index hospitalization (*up to 45 days post admission day while in hospital)
Number of Participants With Renal Failure Requiring Renal Replacement Therapy
Time frame: During index hospitalization - day of admission up to 45 days post admission while in hospital
Number of Participants With Ventilator Associated Pneumonia
Time frame: During index hospitalization - from day of admission up to 45 days post admission (while in hospital)
Number of Participants With Stent Thrombosis
Time frame: Within 6 months of their admission
Number of Participants Discharged Home
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34665203Le 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.
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel R Le May, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Hypothermia in people with Cardiac Arrest, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Death or Poor Neurologic Outcome at 6 Months (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02011568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.