UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048025 |
|---|---|
| Receipt number | R000054741 |
| Scientific Title | Diagnostic accuracy of Focused Cardiac ultrasonography for cause of circulatory failure: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2022/06/10 |
| Last modified on | 2023/10/02 12:58:55 |
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Basic information
Public title
Diagnostic accuracy of Focused Cardiac ultrasonography for cause of circulatory failure: A systematic review and meta-analysis
Acronym
Diagnostic accuracy of FOCUS for cause of circulatory failure
Scientific Title
Diagnostic accuracy of Focused Cardiac ultrasonography for cause of circulatory failure: A systematic review and meta-analysis
Scientific Title:Acronym
Diagnostic accuracy of FOCUS for cause of circulatory failure
Region
| Japan |
Condition
Condition
Adult patients with circulatory failure for which the cause has not been identified
Classification by specialty
| Emergency medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this systematic review and meta-analysis is to obtain summary estimates of diagnostic performance for point of care echocardiography for circulatory failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
True positives, false positives, true negatives, and false negatives
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Studies meeting the following criteria: enrolled adult patients with circulatory failure for which the cause has not been identified; evaluated the diagnostic accuracy of point of care echocardiography for identifying the cause of circulatory failure.
Key exclusion criteria
Case-control studies (two-gate study) and case studies that lacked diagnostic test accuracy data.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Takuo |
| Middle name | |
| Last name | Yoshida |
Organization
Yokohama City University
Division name
Department of Health Data Science, Graduate School of Data Science
Zip code
236-0027
Address
22-2 Seto, Kanazawa, Yokohama 236-0027, Japan
TEL
0457872311
hawaii28981@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takuo |
| Middle name | |
| Last name | Yoshida |
Organization
Yokohama City University
Division name
Department of Health Data Science, Graduate School of Data Science
Zip code
236-0027
Address
22-2 Seto, Kanazawa, Yokohama 236-0027, Japan
TEL
0457872311
Homepage URL
hawaii28981@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2022 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
https://ccforum.biomedcentral.com/articles/10.1186/s13054-023-04495-6
Publication of results
Published
Result
URL related to results and publications
https://ccforum.biomedcentral.com/articles/10.1186/s13054-023-04495-6
Number of participants that the trial has enrolled
12
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
Main results already published
Date of protocol fixation
| 2022 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study protocol is attached in this pre-registration or can be seen at http://www-user.yokohama-cu.ac.jp/~masuika/protocol/. We adhere to the methodological standards outlined in the Handbook for DTA Reviews of Cochrane and used the Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies in reporting our findings.
We will search the Medical Literature Analysis and Retrieval System Online (MEDLINE) via PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and Web of Science. We will conduct further surveillance searches using the related articles feature. In addition, we will search the following pre-registration sites: the Clinicaltrial.gov, the European Union Clinical Trials Register (EU-CTR), the WHO International Clinical Trials Registry Platform (ICTRP), and the University Hospital Medical Information Network Clinical Trials Registry (UMIN).
Management information
Registered date
| 2022 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054741
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
