UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005065 |
|---|---|
| Receipt number | R000005874 |
| Scientific Title | The prospective observational multi-center study about regional cerebral oxygen saturation for prediction of neurological outcomes in patients after out-of-hospital cardiac arrest |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2014/07/23 09:10:18 |
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Basic information
Public title
The prospective observational multi-center study about regional cerebral oxygen saturation for prediction of neurological outcomes in patients after out-of-hospital cardiac arrest
Acronym
J-POP trial (Prediction of neurological Outcomes in patients Post cardiac arrest trial)
Scientific Title
The prospective observational multi-center study about regional cerebral oxygen saturation for prediction of neurological outcomes in patients after out-of-hospital cardiac arrest
Scientific Title:Acronym
J-POP trial (Prediction of neurological Outcomes in patients Post cardiac arrest trial)
Region
| Japan |
Condition
Condition
Out-of-hospital cardiac arrest
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the capability of regional brain oxygen saturation (rSO2) obtained immediately on arrival at the hospital to predict neurological outcomes in patients after out-of hospital cardiac arrest.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CPC (Glasgow-Pittsburgh Cerebral Performance Categories) at 30 days and 3 months after out-of hospital cardiac arrest.
Key secondary outcomes
CPC (Glasgow-Pittsburgh Cerebral Performance Categories) at hospital 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 cardiac arrest on arrival after out-of hospital cardiac arrest, or patients with return to spontaneous circulation and comatose on arrival after out-of hospital cardiac arrest
Key exclusion criteria
Out-of hospital cardiac arrest from a traumatic origin with uncontrolled bleeding, or patients with previous completion of a <Do Not Attempt Resuscitation> form
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Nishiyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Primary Care and Emergency Medicine
Zip code
Address
54 Kawahara-chou, Shogoin, Sakyo-ku, 606-8507 Japan
TEL
0757513126
keinishi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Nishiyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Primary Care and Emergency Medicine
Zip code
Address
54 Kawahara-chou, Shogoin, Sakyo-ku, 606-8507 Japan
TEL
0757513126
Homepage URL
keinishi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Osaka Saiseikai Senri Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Primary Care and Emergency Medicine, Kyoto University Graduate
School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪市立総合医療センター 救命救急センター（大阪府）
東北大学 高度救命救急センター (宮城県）
奈良県立医科大学 高度救命救急センター（奈良県）
藤沢市民病院 救命救急センター（神奈川県）
岐阜大学 高度救命救急センター（岐阜県）
京都桂病院（京都府）
慶應義塾大学 救急科（東京都）
国立病院機構 京都医療センター 循環器内科、救命救急センター（京都府）
済生会横浜市東部病院 救命救急センター（神奈川県）
福岡大学病院 救命救急センター（福岡県）
獨協医科大学（栃木県）
聖隷三方原病院（静岡県）
聖路加国際病院（東京都）
三重大学（三重県）
武蔵野赤十字病院（東京都）
京都大学医学研究科 初期診療・救急医学分野（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/24606889
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24606889
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
| 2011 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 01 | Day |
Other
Other related information
This study is prospective observational multi center study. In this study receiver operating characteristic (ROC) analysis is performed to evaluate the diagnostic accuracy of rSO2 in predicting good neurological outcome (CPC1,2) in patients after out-of hospital cardiac arrest.
Management information
Registered date
| 2011 | Year | 02 | Month | 10 | Day |
Last modified on
| 2014 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005874
