UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001935
Receipt No. R000002348
Scientific Title Multicenter registry study with therapeutic hypothermia after cardiac arrest in Japan
Date of disclosure of the study information 2009/05/02
Last modified on 2010/08/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicenter registry study with therapeutic hypothermia after cardiac arrest in Japan
Acronym J-PULSE-HYPO study
Scientific Title Multicenter registry study with therapeutic hypothermia after cardiac arrest in Japan
Scientific Title:Acronym J-PULSE-HYPO study
Region
Japan

Condition
Condition Cardiac Arrest
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recently, early defibrillation and 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Survival and functional outcome (CPC: Cerebral Performance Categories) after 3 months
Key secondary outcomes Survival and/or functional outcome after 24 hours, 7days, 1 months, 3 months, and at discharge

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with therapeutic
hypothermia after cardiac arrest from 2005 to 2009 in each hospitals.

Inclusion criteria:
Adult (more than 18 years old) patients who remained unconscious after resuscitation from out-of-hospital or inhospital cardiac arrest and presented the stable hemodynamics with drug treatments or mechanical supporting system including IABP or PCPS.
Key exclusion criteria Exclusion criteria: Patients with
pregnancy, acute aortic dissection,
pulmonary thromboembolism, drug
poisoning or poor daily activity
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nonogi
Organization National Cardiovascular Center
Division name Department of Cardiology
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Nonogi
Organization National Cardiovascular Center
Division name Department of Cardiology
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka
TEL
Homepage URL
Email

Sponsor
Institute National Cardiovascular Center
Institute
Department

Funding Source
Organization H19-Shinkin-03
The study for the establishment of the prehospital system in acute myocardial infarction and stroke
(J-PULSE2)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 05 Month 01 Day
Date trial data considered complete
2010 Year 06 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information Multicenter registry study (retrospective and prospective cohort study)

Management information
Registered date
2009 Year 05 Month 02 Day
Last modified on
2010 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002348

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.