UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046346 |
|---|---|
| Receipt number | R000052840 |
| Scientific Title | A prospective cohort validation study of predictive score for in-hospital mortality of elderly patients with endogenous diseases transferred by ambulance |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2021/12/10 10:42:04 |
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Basic information
Public title
A prospective cohort validation study of predictive score for in-hospital mortality of elderly patients with endogenous diseases transferred by ambulance
Acronym
A validation study of predictive score for in-hospital mortality of elderly patients transferred by ambulance
Scientific Title
A prospective cohort validation study of predictive score for in-hospital mortality of elderly patients with endogenous diseases transferred by ambulance
Scientific Title:Acronym
A validation study of predictive score for in-hospital mortality of elderly patients transferred by ambulance
Region
| Japan |
Condition
Condition
Inpatients transported by ambulance
Classification by specialty
| Medicine in general | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the accuracy of the predictive score for in-hospital mortality, which we developed in the previous study, in a prospective study.
Basic objectives2
Others
Basic objectives -Others
in-hospital mortality
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
in-hospital mortality
Key secondary outcomes
likelihood ratio, AUC
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects were consecutive patients aged 65 years or older with endogenous diseases, all of whom were transported by ambulance and admitted to Yuai-Kai Foundation and Oda Hospital during the period April 2019 to March 2020.
Key exclusion criteria
exogenous diseases, cardiopulmonary arrest on arrival, death on emergency room, transferred to other tertiary care hospital within 6 hours after emergency transport
Target sample size
252
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
81-952-34-3238
tagomas@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
81-952-34-3238
Homepage URL
tagomas@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Hospital General Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yuai-Kai Foundation and Oda Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yuai-Kai Foundation and Oda Hospital
Address
4306 Takatsuhara, Kashima, Saga 849-1311, Japan
Tel
81-954-63-3275
renkei@yuai-hc.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
| 2021 | Year | 12 | Month | 10 | 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
325
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It was delayed because additional analysis was required.
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
| 2018 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All elderly patients aged 65 years or older with endogenous diseases transferred by ambulance were enrolled in a single-center prospective cohort study. In addition, age, sex, vital signs (blood pressure, pulse rate, respiration rate, SpO2), amount of oxygen administered, level of consciousness, past medical history, prescribed medications, bedriddenness rank, cognitive function score, ABC-DS, and Barthel index were collected.
Management information
Registered date
| 2021 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052840
