UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007528
Receipt No. R000008833
Scientific Title Comprehensive Registry of Intensive Cares for OHCA Survival (CRITICAL) Study
Date of disclosure of the study information 2012/04/01
Last modified on 2021/03/08

* 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 Comprehensive Registry of Intensive Cares for OHCA Survival (CRITICAL) Study
Acronym Comprehensive Registry of Intensive Cares for OHCA Survival (CRITICAL) Study
Scientific Title Comprehensive Registry of Intensive Cares for OHCA Survival (CRITICAL) Study
Scientific Title:Acronym Comprehensive Registry of Intensive Cares for OHCA Survival (CRITICAL) Study
Region
Japan

Condition
Condition Cardiac arrest
Classification by specialty
Cardiology Pediatrics Emergency medicine
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the standard of adequate transport system and verify the effectiveness of post-hospital care, we lunch comprehensive cohort registry so that we could evaluate out-of- and in-hospital cares.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes One-month survivalor 90days survivalor with favorable neurological outcome, defined as CPC category 1 or 2.
Key secondary outcomes Return ofspontaneous circulation,admission to the hospital,and 1-month survival or 90days survaival.

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
0 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria General public living in Osaka ,those who had an OHCA and who were treated by EMS personnel, and then transported to medical institutions.
Key exclusion criteria 1.In hospital death(IHCA) cases
2.General public living in outof Osaka.
Target sample size 2400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iwami Taku
Organization Kyoto University
Division name Health service
Zip code
Address Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501
TEL 075-753-2431
Email iwamit@e-mail.jp

Public contact
Name of contact person
1st name
Middle name
Last name Okamoto Yoshio
Organization Okayama University
Division name Pediatrics
Zip code
Address Shikata-cho. Kita-ku,Okayama.700-8558
TEL 086-235-6643
Homepage URL
Email tarotaro1500m@yahoo.co.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Heisei 24 fiscal year Research Grant-in-Aid for Scientific Research Ministry of Education, Culture, Sports, Science :Comprehensive Registry of Intensive Cares for OHCA Survival
(CRITICAL) Study
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kyoto University
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
2012 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2012 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2017 Year 03 Month 01 Day
Date of closure to data entry
2017 Year 04 Month 01 Day
Date trial data considered complete
2017 Year 08 Month 01 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information Outcome of OHCA not transported to crtical care center is 1% ,and If OHCA transported to crtical care center,outcome of OHCA will be twice. Consider the 1:4 ratio that tne number of cases. We need total size is 2400.

Management information
Registered date
2012 Year 03 Month 19 Day
Last modified on
2021 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008833

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.