Cardiac ArrestNCT01617291
Therapeutic Hypothermia After the Return of Spontaneous Circulation
A study testing Induced therapeutic hypothermia in people with Cardiac Arrest, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the pre-hospital setting of a four county emergency medical system (EMS) that serves both urban and rural communities improves meaningful survival from medical cardiac arrest. 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?
- Induced therapeutic hypothermia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Feb 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patient transported by CCEMS with ROSC after a medical Cardiac Arrest to hospitals that can continue ITH
Who cannot join
- Less than 18
- Cardiac arrest due to trauma or hemorrhage
- Pregnant women
- patients whom are already hypothermic
- transported to a hospital that can not maintain hypothermia for 24 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Regional Medical Center
Fresno, California, 93701
About this study
Official title: Induction of Therapeutic Hypothermia in the Pre-hospital Setting After the Return on Spontaneous Circulation: A Randomized Controlled Study
The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the pre-hospital setting of a four county emergency medical system (EMS) that serves both urban and rural communities improves meaningful survival from medical cardiac arrest.
Read the detailed description
Induction of therapeutic hypothermia after return of spontaneous circulation (ROSC) in medical cardiac arrest is increasingly becoming the standard of care in the hospital setting. Several studies, including two sentinel research papers in the New England Journal of Medicine, show improved neurologic outcome with induced therapeutic hypothermia (ITH). 4, 5 This research led to a class IIa recommendation by the American Heart Association for ITH after ROSC in V-Fib arrest and a class IIb recommendation after ROSC in all other classes of medial cardiac arrest.6
The role of ITH in the pre-hospital setting is less clear. Studies currently exist that both show a benefit and fail to support improved outcomes.7-9 It has been suggested that the short transport times in most urban EMS systems might be part of the reason that some studies have failed to find benefit of ITH in the pre-hospital setting.
This is a prospective, randomized controlled trial involving all patients transported by CCEMS who have ROSC after a medical cardiac arrest and who are transported to a hospital that can continue ITH for 24 hours. All comatose patients who meet inclusion criteria will be randomized to either ITH in addition to continued treatment under standing protocols or regular care without ITH. Assignment to the two treatment arms will be done using the EMS number which is generated when the ambulance is dispatched to a call. Even numbered patients will have continued standard therapy while odd numbered patients will receive ITH.
- Conditions
- Cardiac Arrest
- Being tested
- Induced therapeutic hypothermia
- Keywords
- Pre-hospital hypothermia, Induced therapeutic hypothermia, Cardiac arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced therapeutic hypothermiaOther
Also called Medical Arrest, Cardiac Arrest, Return of spontaneous circulation, ROSC
induced therapeutic hypothermia
| Study group | Role | What they receive |
|---|---|---|
| Induced Hypothermia | Experimental | Induced hypothermia after the return of spontaneous circulation by the application of ice packs to the axilla and groin with cold IV fluids Receives: Other: Induced therapeutic hypothermia |
| Regular Care | No intervention | Treatment of the return of spontaneous circulation under standing paramedic protocol without the addition of induced therapeutic hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induced therapeutic hypothermia in the pre-hospital setting improves outcomes
Induced hypothermia and continued treatment under standing paramedic protocols. To determine if ITH in the pre-hospital setting improves outcomes at hospital discharge
Measured: followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated
Secondary outcomes (1)
Regular treatment without induced therapeutic hypothermia
Patients will be treated under standing paramedic protocols without the induction of hypothermia. To determine if there is a difference in these outcomes in patients with prolonged transport to the hospital (> 20 minutes) versus those with shorter transport times.
Measured: followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: A similar study was recently published with definitive results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 University of California, San FranciscoThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Weichenthal, University of California, San Francisco
- Investigators
- Lori Weichenthal, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617291
- Sponsor's protocol ID
- 2012051
- Status last verified
- Feb 2014
- First submitted
- 27 May 2012
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Finn JC, Bett JH, Shilton TR, Cunningham C, Thompson PL; National Heart Foundation of Australia Chest Pain Every Minute Counts Working Group. Patient delay in responding to symptoms of possible heart attack: can we reduce time to care? Med J Aust. 2007 Sep 3;187(5):293-8. doi: 10.5694/j.1326-5377.2007.tb01247.x.
PubMed 17767436Fridman M, Barnes V, Whyman A, Currell A, Bernard S, Walker T, Smith KL. A model of survival following pre-hospital cardiac arrest based on the Victorian Ambulance Cardiac Arrest Register. Resuscitation. 2007 Nov;75(2):311-22. doi: 10.1016/j.resuscitation.2007.05.005. Epub 2007 Jun 20.
PubMed 17583414Jennings PA, Cameron P, Walker T, Bernard S, Smith K. Out-of-hospital cardiac arrest in Victoria: rural and urban outcomes. Med J Aust. 2006 Aug 7;185(3):135-9. doi: 10.5694/j.1326-5377.2006.tb00498.x.
PubMed 16893352Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86.
PubMed 10625721Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
PubMed 11856794Guidelines for cardiopulmonary resuscitation and emergency cardiac care. Emergency Cardiac Care Committee and Subcommittees, American Heart Association. Part IV. Special resuscitation situations. JAMA. 1992 Oct 28;268(16):2242-50. No abstract available.
PubMed 1404770Hinchey PR, Myers JB, Lewis R, De Maio VJ, Reyer E, Licatese D, Zalkin J, Snyder G; Capital County Research Consortium. Improved out-of-hospital cardiac arrest survival after the sequential implementation of 2005 AHA guidelines for compressions, ventilations, and induced hypothermia: the Wake County experience. Ann Emerg Med. 2010 Oct;56(4):348-57. doi: 10.1016/j.annemergmed.2010.01.036. Epub 2010 Mar 31.
PubMed 20359771Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper DJ, Kelly AM, Silvester W; Rapid Infusion of Cold Hartmanns (RICH) Investigators. Induction of therapeutic hypothermia by paramedics after resuscitation from out-of-hospital ventricular fibrillation cardiac arrest: a randomized controlled trial. Circulation. 2010 Aug 17;122(7):737-42. doi: 10.1161/CIRCULATIONAHA.109.906859. Epub 2010 Aug 2.
PubMed 20679551Cabanas JG, Brice JH, De Maio VJ, Myers B, Hinchey PR. Field-induced therapeutic hypothermia for neuroprotection after out-of hospital cardiac arrest: a systematic review of the literature. J Emerg Med. 2011 Apr;40(4):400-9. doi: 10.1016/j.jemermed.2010.07.002. Epub 2010 Sep 17.
PubMed 20850254
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Therapeutic Hypothermia in the Pre-hospital Setting After the Return on Spontaneous Circulation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01617291
- Acronym / sponsor ID
- 2012051
- Conditions
- Cardiac Arrest
- Keywords
- Pre-hospital hypothermia, Induced therapeutic hypothermia, Cardiac arrest
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A similar study was recently published with definitive results.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Jun 2012 (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.
The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the pre-hospital setting of a four county emergency medical system (EMS) that serves both urban and rural communities improves meaningful survival from medical cardiac arrest.
Detailed description
Induction of therapeutic hypothermia after return of spontaneous circulation (ROSC) in medical cardiac arrest is increasingly becoming the standard of care in the hospital setting. Several studies, including two sentinel research papers in the New England Journal of Medicine, show improved neurologic outcome with induced therapeutic hypothermia (ITH). 4, 5 This research led to a class IIa recommendation by the American Heart Association for ITH after ROSC in V-Fib arrest and a class IIb recommendation after ROSC in all other classes of medial cardiac arrest.6
The role of ITH in the pre-hospital setting is less clear. Studies currently exist that both show a benefit and fail to support improved outcomes.7-9 It has been suggested that the short transport times in most urban EMS systems might be part of the reason that some studies have failed to find benefit of ITH in the pre-hospital setting.
This is a prospective, randomized controlled trial involving all patients transported by CCEMS who have ROSC after a medical cardiac arrest and who are transported to a hospital that can continue ITH for 24 hours. All comatose patients who meet inclusion criteria will be randomized to either ITH in addition to continued treatment under standing protocols or regular care without ITH. Assignment to the two treatment arms will be done using the EMS number which is generated when the ambulance is dispatched to a call. Even numbered patients will have continued standard therapy while odd numbered patients will receive ITH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induced Hypothermia | Experimental | Other: Induced therapeutic hypothermiaInduced hypothermia after the return of spontaneous circulation by the application of ice packs to the axilla and groin with cold IV fluids |
| Regular Care | No intervention | –Treatment of the return of spontaneous circulation under standing paramedic protocol without the addition of induced therapeutic hypothermia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patient transported by CCEMS with ROSC after a medical Cardiac Arrest to hospitals that can continue ITH
Key exclusion criteria (5 listed)
- Less than 18
- Cardiac arrest due to trauma or hemorrhage
- Pregnant women
- patients whom are already hypothermic
- transported to a hospital that can not maintain hypothermia for 24 hours
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 |
|---|---|---|
| Induced therapeutic hypothermiaAlso: Medical Arrest, Cardiac Arrest, Return of spontaneous circulation, ROSCinduced therapeutic hypothermia | Other | Induced Hypothermia |
Primary outcome
Induced therapeutic hypothermia in the pre-hospital setting improves outcomes
Time frame: followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated
Induced hypothermia and continued treatment under standing paramedic protocols. To determine if ITH in the pre-hospital setting improves outcomes at hospital discharge
1 secondary outcome
Regular treatment without induced therapeutic hypothermia
Time frame: followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated
Results and safety
The study was stopped early (reason given: A similar study was recently published with definitive results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
- Background: PubMed 17767436Finn JC, Bett JH, Shilton TR, Cunningham C, Thompson PL; National Heart Foundation of Australia Chest Pain Every Minute Counts Working Group. Patient delay in responding to symptoms of possible heart attack: can we reduce time to care? Med J Aust. 2007 Sep 3;187(5):293-8. doi: 10.5694/j.1326-5377.2007.tb01247.x.
- Background: PubMed 17583414Fridman M, Barnes V, Whyman A, Currell A, Bernard S, Walker T, Smith KL. A model of survival following pre-hospital cardiac arrest based on the Victorian Ambulance Cardiac Arrest Register. Resuscitation. 2007 Nov;75(2):311-22. doi: 10.1016/j.resuscitation.2007.05.005. Epub 2007 Jun 20.
- Background: PubMed 16893352Jennings PA, Cameron P, Walker T, Bernard S, Smith K. Out-of-hospital cardiac arrest in Victoria: rural and urban outcomes. Med J Aust. 2006 Aug 7;185(3):135-9. doi: 10.5694/j.1326-5377.2006.tb00498.x.
- Background: PubMed 10625721Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86.
- Background: PubMed 11856794Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
- Background: PubMed 1404770Guidelines for cardiopulmonary resuscitation and emergency cardiac care. Emergency Cardiac Care Committee and Subcommittees, American Heart Association. Part IV. Special resuscitation situations. JAMA. 1992 Oct 28;268(16):2242-50. No abstract available.
- Background: PubMed 20359771Hinchey PR, Myers JB, Lewis R, De Maio VJ, Reyer E, Licatese D, Zalkin J, Snyder G; Capital County Research Consortium. Improved out-of-hospital cardiac arrest survival after the sequential implementation of 2005 AHA guidelines for compressions, ventilations, and induced hypothermia: the Wake County experience. Ann Emerg Med. 2010 Oct;56(4):348-57. doi: 10.1016/j.annemergmed.2010.01.036. Epub 2010 Mar 31.
- Background: PubMed 20679551Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper DJ, Kelly AM, Silvester W; Rapid Infusion of Cold Hartmanns (RICH) Investigators. Induction of therapeutic hypothermia by paramedics after resuscitation from out-of-hospital ventricular fibrillation cardiac arrest: a randomized controlled trial. Circulation. 2010 Aug 17;122(7):737-42. doi: 10.1161/CIRCULATIONAHA.109.906859. Epub 2010 Aug 2.
- Background: PubMed 20850254Cabanas JG, Brice JH, De Maio VJ, Myers B, Hinchey PR. Field-induced therapeutic hypothermia for neuroprotection after out-of hospital cardiac arrest: a systematic review of the literature. J Emerg Med. 2011 Apr;40(4):400-9. doi: 10.1016/j.jemermed.2010.07.002. Epub 2010 Sep 17.
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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.
Lori Weichenthal, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induced therapeutic hypothermia in people with Cardiac Arrest, run by University of California, San Francisco at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 14 Feb 2014. 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 United States. 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?
The study was stopped early (reason given: A similar study was recently published with definitive results.). Results are not available in the source record.
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?
Induced therapeutic hypothermia in the pre-hospital setting improves outcomes (time frame: followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated). 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 NCT01617291, which also lists 9 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 14 Feb 2014.