Cardiac ArrestSPARCNCT00683683
The Strategies for Post Arrest Resuscitation and Care Network
A study testing Knowledge Translation in people with Cardiac Arrest, run by Unity Health Toronto.
Trial summary
Background: One of the 2010 Impact Goals of the Emergency Cardiac Care (ECC) Committee of the American Heart Association is to double survival from cardiac arrest. Currently, approximately 60% of adults and 50% of paediatric patients that regain spontaneous circulation following cardiac arrest die before leaving the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Knowledge Translation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitals participating in the ROC network
Who cannot join
- Hospitals who do not receive out-of-hospital cardiac arrest patients
About this study
Background: One of the 2010 Impact Goals of the Emergency Cardiac Care (ECC) Committee of the American Heart Association is to double survival from cardiac arrest. Currently, approximately 60% of adults and 50% of paediatric patients that regain spontaneous circulation following cardiac arrest die before leaving the hospital. A key piece of the "chain of survival" is this fifth link; the care of patients post-arrest. Although there are several modalities recommended for post arrest care, therapeutic hypothermia is the only in-hospital therapy that has been demonstrated in randomized clinical trials to improve patient outcome after cardiac arrest. Despite the strong evidence for its efficacy and the apparent simplicity of this intervention, recent surveys show that hypothermia is delivered inconsistently, incompletely, and with undue delay in hospitals receiving resuscitated patients; only 26% of physicians and 26% of hospitals regularly institute a hypothermia protocol.
Primary Objective: To design and apply a knowledge translation program for the 2005 AHA guideline on hypothermia post cardiac arrest and enable effective implementation of hypothermia in 100% of eligible OHCA patients. The integration of two robust data collection systems, which include both pre-hospital and in-hospital indicators, will give complete process of care and clinical outcome information for all cardiac arrest patients.
Read more
Primary Endpoint: the proportion of eligible out of hospital cardiac arrest patients cooled to 32-34°C within 6 hours of ED arrival.
Study Design: This project will be implemented through an established research collaborative of 43 hospitals in southern Ontario currently participating in the Toronto site of the Resuscitation Outcomes Consortium. A stepped wedge study design will be employed, whereby the intervention will be rolled-out sequentially to the participating hospitals over a number of time periods as sites reach pre-defined benchmarks. The multifaceted KT strategy will include 1) local multidisciplinary champions in ED, ICU, and Cardiology 2) A simple protocol for application of hypothermia, tailored to local needs and policy; 3) Identification of perceived and actual barriers to knowledge use; 4) Development of an implementation tool kit and 5) Providing timely feedback on benchmarks for hypothermia and outcomes
Read the detailed description
Substantial resources are spent in providing emergency medical services to victims of out-of-hospital cardiac arrest. The science of pre-hospital medicine has advanced considerably over the past decade. Specifically, EMS services and medical directors have developed carefully designed protocols, intensive training, and very substantial resources, in attempting to improve the immediate outcomes in patients with out-of-hospital cardiac arrest. It is anticipated that approximately 200-400 patients per year in the Greater Toronto Area are successfully resuscitated by Emergency Medical Services personnel and be admitted to hospital with intact circulatory function.
Unfortunately, many of these patients will then die following hospital admission, from one of a variety of complications of the initial cardiac arrest. The "in-hospital attrition rate" is approximately 50%, and is the result of short and longer-term organ damage suffered during the circulatory arrest, as well as in-hospital complications including pulmonary, neurological, septic, and multi-organ dysfunction related complications.
Although guidelines for specific aspects of intensive care therapy of critically ill patients have been developed (for example, ventilation guidelines, sepsis prevention and therapy guidelines, treatment of metabolic disorders, etc), practical guidelines, which are specifically aimed at the investigation and treatment of patients resuscitated from out-of-hospital cardiac arrest, do not currently exist.
Preliminary studies (in press) suggest that a program of comprehensive and consistent adherence to a specific set of standard procedures in intensive care units can lead to a substantial improvement in the survival of patients resuscitated from cardiac arrest. One recent example is a study from Oslo Norway, which showed substantial improvements in survival to discharge following out-of-hospital cardiac arrest after a set of informal guidelines were adopted by participating intensive care units.
There are multiple reasons for the lack of clearly articulated guidelines and protocols for the investigation and treatment of patients resuscitated following cardiac arrest however the two most obvious are lack of understanding of the current recommended best practices and practical impediments to their efficient implementation in all units.
The Resuscitation Outcomes Consortium (ROC), an NIH funded multi-centre effort, seeks to randomize over 10,000 patients in selected North American sites to study specific interventions designed to improve long term survival in patients with out-of-hospital cardiac arrest. As part of this consortium, intensive care units in the ROC hospitals are being invited to join a new best practice initiative entitled "Strategies for Post Arrest Care in the ICU" (SPARC).
Working with more than 50 hospitals across Ontario, the objectives of the SPARC Project are planned as follows:
- To establish a network of intensive care units, with medical and nursing leaders who will participate in a collaborative program designed to standardize, monitor, and improve the care of patients resuscitated from out-of-hospital cardiac arrest.
- To develop a series of standardized protocols and processes for the care of patients following out-of-hospital cardiac arrest, with particular emphasis on the delivery of post cardiac arrest mild hypothermia. These protocols will be based on best evidence to date and will focus on the simplifying the processes required implement the recommended interventions.
- To conduct pragmatic clinical trials of the integrated post cardiac arrest protocol versus historical controls, and study related patient outcomes such as survival to hospital discharge. We will also look to provide a comprehensive assessment of in-hospital complications, the incidence of presumed myocardial ischemic events causing cardiac arrest, and to assess the causes of in-hospital and post discharge morbidity and mortality for the one year following discharge, as a function of the presumed underlying cause of cardiac arrest and the in-hospital course.
- Conditions
- Cardiac Arrest
- Being tested
- Knowledge Translation
- Keywords
- cardiac arrest, hypothermia, knowledge translation
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge TranslationBehavioural
Also called Clinical Protocol;, Reminders;, Audit & Feedback;, Network
The multifaceted KT strategy will include 1) local multidisciplinary champions in ED, ICU, and Cardiology 2) A simple protocol for application of hypothermia, tailored to local needs and policy; 3) Identification of perceived and actual barriers to knowledge use; 4) Development of an implementation tool kit and 5) Providing timely feedback on benchmarks for hypothermia and outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Cooling | Other | Cardiac arrest patients will be cooled to 32-34°C within 6 hours of ED arrival Receives: Behavioral: Knowledge Translation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of eligible out of hospital cardiac arrest patients cooled to 32-34°C within 6 hours of ED arrival.
Measured: Within 6 hours of ED arrival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Unity Health TorontoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Laerdal Medical
- Responsible party
- Principal investigator, Laurie Morrison, Unity Health Toronto
- Investigators
- Laurie Morrison, MD, MSc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683683
- Sponsor's protocol ID
- SPARC (Morrison 038-2008)
- Acronym
- SPARC
- Status last verified
- May 2014
- First submitted
- 15 May 2008
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morrison LJ, Brooks SC, Dainty KN, Dorian P, Needham DM, Ferguson ND, Rubenfeld GD, Slutsky AS, Wax RS, Zwarenstein M, Thorpe K, Zhan C, Scales DC; Strategies for Post-Arrest Care Network. Improving use of targeted temperature management after out-of-hospital cardiac arrest: a stepped wedge cluster randomized controlled trial. Crit Care Med. 2015 May;43(5):954-64. doi: 10.1097/CCM.0000000000000864.
PubMed 25654175Dainty KN, Scales DC, Brooks SC, Needham DM, Dorian P, Ferguson N, Rubenfeld G, Wax R, Zwarenstein M, Thorpe K, Morrison LJ. A knowledge translation collaborative to improve the use of therapeutic hypothermia in post-cardiac arrest patients: protocol for a stepped wedge randomized trial. Implement Sci. 2011 Jan 14;6:4. doi: 10.1186/1748-5908-6-4.
PubMed 21235799
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Strategies for Post Arrest Resuscitation and Care Network
- ClinicalTrials.gov ID
- NCT00683683
- Acronym / sponsor ID
- SPARC / SPARC (Morrison 038-2008)
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, hypothermia, knowledge translation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Laerdal Medical
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: One of the 2010 Impact Goals of the Emergency Cardiac Care (ECC) Committee of the American Heart Association is to double survival from cardiac arrest. Currently, approximately 60% of adults and 50% of paediatric patients that regain spontaneous circulation following cardiac arrest die before leaving the hospital. A key piece of the "chain of survival" is this fifth link; the care of patients post-arrest. Although there are several modalities recommended for post arrest care, therapeutic hypothermia is the only in-hospital therapy that has been demonstrated in randomized clinical trials to improve patient outcome after cardiac arrest. Despite the strong evidence for its efficacy and the apparent simplicity of this intervention, recent surveys show that hypothermia is delivered inconsistently, incompletely, and with undue delay in hospitals receiving resuscitated patients; only 26% of physicians and 26% of hospitals regularly institute a hypothermia protocol.
Primary Objective: To design and apply a knowledge translation program for the 2005 AHA guideline on hypothermia post cardiac arrest and enable effective implementation of hypothermia in 100% of eligible OHCA patients. The integration of two robust data collection systems, which include both pre-hospital and in-hospital indicators, will give complete process of care and clinical outcome information for all cardiac arrest patients.
Primary Endpoint: the proportion of eligible out of hospital cardiac arrest patients cooled to 32-34°C within 6 hours of ED arrival.
Study Design: This project will be implemented through an established research collaborative of 43 hospitals in southern Ontario currently participating in the Toronto site of the Resuscitation Outcomes Consortium. A stepped wedge study design will be employed, whereby the intervention will be rolled-out sequentially to the participating hospitals over a number of time periods as sites reach pre-defined benchmarks. The multifaceted KT strategy will include 1) local multidisciplinary champions in ED, ICU, and Cardiology 2) A simple protocol for application of hypothermia, tailored to local needs and policy; 3) Identification of perceived and actual barriers to knowledge use; 4) Development of an implementation tool kit and 5) Providing timely feedback on benchmarks for hypothermia and outcomes
Detailed description
Substantial resources are spent in providing emergency medical services to victims of out-of-hospital cardiac arrest. The science of pre-hospital medicine has advanced considerably over the past decade. Specifically, EMS services and medical directors have developed carefully designed protocols, intensive training, and very substantial resources, in attempting to improve the immediate outcomes in patients with out-of-hospital cardiac arrest. It is anticipated that approximately 200-400 patients per year in the Greater Toronto Area are successfully resuscitated by Emergency Medical Services personnel and be admitted to hospital with intact circulatory function.
Unfortunately, many of these patients will then die following hospital admission, from one of a variety of complications of the initial cardiac arrest. The "in-hospital attrition rate" is approximately 50%, and is the result of short and longer-term organ damage suffered during the circulatory arrest, as well as in-hospital complications including pulmonary, neurological, septic, and multi-organ dysfunction related complications.
Although guidelines for specific aspects of intensive care therapy of critically ill patients have been developed (for example, ventilation guidelines, sepsis prevention and therapy guidelines, treatment of metabolic disorders, etc), practical guidelines, which are specifically aimed at the investigation and treatment of patients resuscitated from out-of-hospital cardiac arrest, do not currently exist.
Preliminary studies (in press) suggest that a program of comprehensive and consistent adherence to a specific set of standard procedures in intensive care units can lead to a substantial improvement in the survival of patients resuscitated from cardiac arrest. One recent example is a study from Oslo Norway, which showed substantial improvements in survival to discharge following out-of-hospital cardiac arrest after a set of informal guidelines were adopted by participating intensive care units.
There are multiple reasons for the lack of clearly articulated guidelines and protocols for the investigation and treatment of patients resuscitated following cardiac arrest however the two most obvious are lack of understanding of the current recommended best practices and practical impediments to their efficient implementation in all units.
The Resuscitation Outcomes Consortium (ROC), an NIH funded multi-centre effort, seeks to randomize over 10,000 patients in selected North American sites to study specific interventions designed to improve long term survival in patients with out-of-hospital cardiac arrest. As part of this consortium, intensive care units in the ROC hospitals are being invited to join a new best practice initiative entitled "Strategies for Post Arrest Care in the ICU" (SPARC).
Working with more than 50 hospitals across Ontario, the objectives of the SPARC Project are planned as follows:
- To establish a network of intensive care units, with medical and nursing leaders who will participate in a collaborative program designed to standardize, monitor, and improve the care of patients resuscitated from out-of-hospital cardiac arrest.
- To develop a series of standardized protocols and processes for the care of patients following out-of-hospital cardiac arrest, with particular emphasis on the delivery of post cardiac arrest mild hypothermia. These protocols will be based on best evidence to date and will focus on the simplifying the processes required implement the recommended interventions.
- To conduct pragmatic clinical trials of the integrated post cardiac arrest protocol versus historical controls, and study related patient outcomes such as survival to hospital discharge. We will also look to provide a comprehensive assessment of in-hospital complications, the incidence of presumed myocardial ischemic events causing cardiac arrest, and to assess the causes of in-hospital and post discharge morbidity and mortality for the one year following discharge, as a function of the presumed underlying cause of cardiac arrest and the in-hospital course.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cooling | Other | Behavioral: Knowledge TranslationCardiac arrest patients will be cooled to 32-34°C within 6 hours of ED arrival |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitals participating in the ROC network
Key exclusion criteria (1 listed)
- Hospitals who do not receive out-of-hospital cardiac arrest patients
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 |
|---|---|---|
| Knowledge TranslationAlso: Clinical Protocol;, Reminders;, Audit & Feedback;, NetworkThe multifaceted KT strategy will include 1) local multidisciplinary champions in ED, ICU, and Cardiology 2) A simple protocol for application of hypothermia, tailored to local needs and policy; 3) Identification of perceived and actual barriers to knowledge use; 4) Development of an implementation tool kit and 5) Providing timely feedback on benchmarks for hypothermia and outcomes. | Behavioural | Cooling |
Primary outcome
The proportion of eligible out of hospital cardiac arrest patients cooled to 32-34°C within 6 hours of ED arrival.
Time frame: Within 6 hours of ED arrival.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 25654175Morrison LJ, Brooks SC, Dainty KN, Dorian P, Needham DM, Ferguson ND, Rubenfeld GD, Slutsky AS, Wax RS, Zwarenstein M, Thorpe K, Zhan C, Scales DC; Strategies for Post-Arrest Care Network. Improving use of targeted temperature management after out-of-hospital cardiac arrest: a stepped wedge cluster randomized controlled trial. Crit Care Med. 2015 May;43(5):954-64. doi: 10.1097/CCM.0000000000000864.
- Derived from this study: PubMed 21235799Dainty KN, Scales DC, Brooks SC, Needham DM, Dorian P, Ferguson N, Rubenfeld G, Wax R, Zwarenstein M, Thorpe K, Morrison LJ. A knowledge translation collaborative to improve the use of therapeutic hypothermia in post-cardiac arrest patients: protocol for a stepped wedge randomized trial. Implement Sci. 2011 Jan 14;6:4. doi: 10.1186/1748-5908-6-4.
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.
Laurie Morrison, MD, MSc principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge Translation in people with Cardiac Arrest, run by Unity Health Toronto.
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 1 inclusion and 1 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of eligible out of hospital cardiac arrest patients cooled to 32-34°C within 6 hours of ED arrival. (time frame: Within 6 hours of ED arrival.). 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 NCT00683683, which also lists 2 linked publications.
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 27 May 2015.