UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054520 |
|---|---|
| Receipt number | R000061919 |
| Scientific Title | A clinical trial to standardize the criteria for termination of resuscitation in out-of-hospital cardiac arrest. |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/03/30 15:05:19 |
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Basic information
Public title
A clinical trial to standardize the criteria for termination of resuscitation in out-of-hospital cardiac arrest.
Acronym
A clinical trial to standardize the criteria for termination of resuscitation in out-of-hospital cardiac arrest.
Scientific Title
A clinical trial to standardize the criteria for termination of resuscitation in out-of-hospital cardiac arrest.
Scientific Title:Acronym
A clinical trial to standardize the criteria for termination of resuscitation in out-of-hospital cardiac arrest.
Region
| Japan |
Condition
Condition
Cardiac arrest
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the criteria for determining termination of resuscitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Specificity of findings at the time of emergency team contact and admission to the hospital for failure to resumption of spontaneous circulation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Additional confirmation of the following findings upon arrival at the emergency department during cardiopulmonary resuscitation:
Electrocardiogram waveform, pupillary findings, location and extent of dead spots, body stiffness, body temperature
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
1.Case of emergency transported
2.Cases aged 18 years or older
3.Case of out-of-hospital cardiac arrest
4.When consent to participate in the research is obtained from the individual or a family member within the third degree of kinship
Key exclusion criteria
1.If the patient and his/her family do not wish to undergo resuscitation during cardiac arrest due to advanced care planning, and the patient is transported without resuscitation.
2.Case where abuse is suspected
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Nakane |
Organization
Faculty of Medicine, Yamagata University
Division name
Department of Emergency and Critical Care Medicine
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata, Japan
TEL
81-23-628-5422
bealive32@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Sakaguchi |
Organization
Faculty of Medicine, Yamagata University
Division name
Department of Emergency and Critical Care Medicine
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata, Japan
TEL
81-23-628-5422
Homepage URL
bealive32@yahoo.co.jp
Sponsor or person
Institute
Faculty of Medicine, Yamagata University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata, Japan
Tel
023-628-5422
yu-ikekenkyu@jm.kj.yamagata-u.ac.jp
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
| 2024 | Year | 06 | 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
| 2024 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061919
