Cardiac ArrestJ-PULSE-HYPONCT00901134
Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan
An observational study of Cardiac Arrest, run by National Cerebral and Cardiovascular Center, Japan at 14 sites in Japan.
Trial summary
Recently, early defibrillation and cardiopulmonary resuscitation (CPR) for sudden onset of cardiac arrest are advancing, however, survival rate is still very low in the world. Furthermore, post-cardiac arrest brain injury is a common cause of morbidity and mortality after successful resuscitation which is urgent issue… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 452 participants
- Where
- 14 sitesJapan
- Study dates
- Jun 2008to Jul 2011
- Phase
- Observational
- 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
Study population: Patients with therapeutic hypothermia after cardiac arrest from 2005 to 2009 in each hospitals.
Who may be able to join
- Adult patients who remained unconscious after resuscitation from out-of-hospital or inhospital cardiac arrest
- Presented the stable hemodynamics with drug treatments or mechanical supporting system including IABP or PCPS
Who cannot join
- Patients with:
- pregnancy
- acute aortic dissection
- pulmonary thromboembolism
- drug poisoning
- poor daily activity
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Hiroshima City Hospital
Hiroshima, Hiroshima
Kokura Memorial Hospital
Kitakyushu, Fukuoka
Osaka City General Hospital
Osaka, Osaka
Osaka Police Hospital
Osaka, Osaka
Sumitomo Hospital
Osaka, Osaka
Saga University Hospital
Saga, Saga-ken
Sapporo City University Hopistal
Sapporo, Hokaido
National Cardiovascular Center
Suita, Osaka, 565-8565
Osaka Saiseikai Senri Hospital
Suita, Osaka
Kagawa University Hospital
Takamatsu, Kagawa-ken
Osaka Mishima Emergency Critical Care Center
Takatsuki, Osaka
Nihon University Surugadai Hospital
Tokyo, Tokyo
Yamaguchi University Hospital
Ube, Yamaguchi
Yokohama City University Medical Center
Yokohama, Kanagawa
About this study
Recently, early defibrillation and cardiopulmonary resuscitation (CPR) for sudden onset of cardiac arrest are advancing, however, survival rate is still very low in the world. Furthermore, post-cardiac arrest brain injury is a common cause of morbidity and mortality after successful resuscitation which is urgent issue to be solved. Therapeutic hypothermia is part of a standardized treatment strategy for comatose survivors of cardiac arrest in the metabolic phase usually about 15 minutes after cardiac arrest. However, the evidences of the efficacy of therapeutic hypothermia are still few. The optimal candidates, temperature, the timing of initiation, the therapeutic windows and the rate for rewarming have not been defined clinically and should be established. The purpose of this research is the improvement in the outcomes for patients with coma after resuscitation from out-of-hospital cardiac arrest using therapeutic hypothermia established from the analysis of multicenter registry data.
- Conditions
- Cardiac Arrest
- Keywords
- therapeutic hypothermia after 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.
| Study group | Role | What they receive |
|---|---|---|
| hypothermia | Patients with therapeutic hypothermia after cardiac arrest in hospitals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival and functional outcome (CPC: Cerebral Performance Categories)
Measured: after 3 months
Secondary outcomes (5)
Survival and/or functional outcome
Measured: after 24 hours
Survival and/or functional outcome
Measured: after 7 days
Survival and/or functional outcome
Measured: after one month
Survival and/or functional outcome
Measured: at discharge
Survival or functional outcome
Measured: after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJun 2008
- Primary completionMar 2010
- Study completionJul 2011
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.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cerebral and Cardiovascular Center, Japan
- Sponsor type
- University, hospital or other
- Investigators
- Hiroshi Nonogi, MD, Principal investigator, Department of Cardiology, National Cardiovascular Center , Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901134
- Sponsor's protocol ID
- NCVC-JPULSE-H
- Other IDs
- UMIN000001935
- Acronym
- J-PULSE-HYPO
- Status last verified
- Jul 2011
- First submitted
- 12 May 2009
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yokoyama H, Nagao K, Hase M, Tahara Y, Hazui H, Arimoto H, Kashiwase K, Sawano H, Yasuga Y, Kuroda Y, Kasaoka S, Shirai S, Yonemoto N, Nonogi H; J-PULSE-Hypo Investigators. Impact of therapeutic hypothermia in the treatment of patients with out-of-hospital cardiac arrest from the J-PULSE-HYPO study registry. Circ J. 2011;75(5):1063-70. doi: 10.1253/circj.cj-11-0137. Epub 2011 Apr 7.
PubMed 21471669Soga T, Nagao K, Sawano H, Yokoyama H, Tahara Y, Hase M, Otani T, Shirai S, Hazui H, Arimoto H, Kashiwase K, Kasaoka S, Motomura T, Kuroda Y, Yasuga Y, Yonemoto N, Nonogi H; J-PULSE-Hypo Investigators. Neurological benefit of therapeutic hypothermia following return of spontaneous circulation for out-of-hospital non-shockable cardiac arrest. Circ J. 2012;76(11):2579-85. doi: 10.1253/circj.cj-12-0448. Epub 2012 Jul 20.
PubMed 22813874
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Registry Study With Therapeutic Hypothermia After Cardiac Arrest in Japan
- ClinicalTrials.gov ID
- NCT00901134
- Acronym / sponsor ID
- J-PULSE-HYPO / NCVC-JPULSE-H
- Conditions
- Cardiac Arrest
- Keywords
- therapeutic hypothermia after cardiac arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- National Cerebral and Cardiovascular Center, JapanUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 May 2009 (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.
Recently, early defibrillation and cardiopulmonary resuscitation (CPR) for sudden onset of cardiac arrest are advancing, however, survival rate is still very low in the world. Furthermore, post-cardiac arrest brain injury is a common cause of morbidity and mortality after successful resuscitation which is urgent issue to be solved. Therapeutic hypothermia is part of a standardized treatment strategy for comatose survivors of cardiac arrest in the metabolic phase usually about 15 minutes after cardiac arrest. However, the evidences of the efficacy of therapeutic hypothermia are still few. The optimal candidates, temperature, the timing of initiation, the therapeutic windows and the rate for rewarming have not been defined clinically and should be established. The purpose of this research is the improvement in the outcomes for patients with coma after resuscitation from out-of-hospital cardiac arrest using therapeutic hypothermia established from the analysis of multicenter registry data.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypothermia | – | –Patients with therapeutic hypothermia after cardiac arrest in hospitals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with therapeutic hypothermia after cardiac arrest from 2005 to 2009 in each hospitals.
Key inclusion criteria (2 listed)
- Adult patients who remained unconscious after resuscitation from out-of-hospital or inhospital cardiac arrest
- Presented the stable hemodynamics with drug treatments or mechanical supporting system including IABP or PCPS
Key exclusion criteria (6 listed)
- Patients with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival and functional outcome (CPC: Cerebral Performance Categories)
Time frame: after 3 months
5 secondary outcomes
Survival and/or functional outcome
Time frame: after 24 hours
Survival and/or functional outcome
Time frame: after 7 days
Survival and/or functional outcome
Time frame: after one month
Survival and/or functional outcome
Time frame: at discharge
Survival or functional outcome
Time frame: after three months
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 22 Jul 2011.
- Results publication: PubMed 21471669Yokoyama H, Nagao K, Hase M, Tahara Y, Hazui H, Arimoto H, Kashiwase K, Sawano H, Yasuga Y, Kuroda Y, Kasaoka S, Shirai S, Yonemoto N, Nonogi H; J-PULSE-Hypo Investigators. Impact of therapeutic hypothermia in the treatment of patients with out-of-hospital cardiac arrest from the J-PULSE-HYPO study registry. Circ J. 2011;75(5):1063-70. doi: 10.1253/circj.cj-11-0137. Epub 2011 Apr 7.
- Derived from this study: PubMed 22813874Soga T, Nagao K, Sawano H, Yokoyama H, Tahara Y, Hase M, Otani T, Shirai S, Hazui H, Arimoto H, Kashiwase K, Kasaoka S, Motomura T, Kuroda Y, Yasuga Y, Yonemoto N, Nonogi H; J-PULSE-Hypo Investigators. Neurological benefit of therapeutic hypothermia following return of spontaneous circulation for out-of-hospital non-shockable cardiac arrest. Circ J. 2012;76(11):2579-85. doi: 10.1253/circj.cj-12-0448. Epub 2012 Jul 20.
- Related InfoLink provided by the sponsor.
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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.
Hiroshi Nonogi, MD principal investigator
Department of Cardiology, National Cardiovascular Center , Japan
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by National Cerebral and Cardiovascular Center, Japan at 14 sites in Japan.
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 2 inclusion and 6 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 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Japan. 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 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?
Survival and functional outcome (CPC: Cerebral Performance Categories) (time frame: after 3 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 NCT00901134, 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 22 Jul 2011.