UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046923 |
|---|---|
| Receipt number | R000053535 |
| Scientific Title | Study on life and physical prognosis of hospitalized patients with aspiration pneumonia |
| Date of disclosure of the study information | 2022/02/17 |
| Last modified on | 2022/08/19 16:37:26 |
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Basic information
Public title
Study on life and physical prognosis of hospitalized patients with aspiration pneumonia
Acronym
Study on life and physical prognosis of hospitalized patients with aspiration pneumonia
Scientific Title
Study on life and physical prognosis of hospitalized patients with aspiration pneumonia
Scientific Title:Acronym
Study on life and physical prognosis of hospitalized patients with aspiration pneumonia
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the life and physical prognosis of patients with aspiration pneumonia
Basic objectives2
Others
Basic objectives -Others
Explain for factors that influence life and physical prognosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
90-day survival
Key secondary outcomes
ability to walk
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All cases
Key exclusion criteria
None
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Yorihide |
| Middle name | |
| Last name | Yanagita |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Rehabilitation Medicine
Zip code
4338558
Address
3453, Mikatahara-cho, Hamamatsu City, Shizuoka Prefecture
TEL
053-436-1251
dependonhero@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yorihide |
| Middle name | |
| Last name | Yanagita |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Rehabilitation Medicine
Zip code
4338558
Address
3453, Mikatahara-cho, Hamamatsu City, Shizuoka Prefecture
TEL
053-436-1251
Homepage URL
dependonhero@yahoo.co.jp
Sponsor or person
Institute
Seirei Mikatahara General Hospital, Department of Rehabilitation Medicine
Institute
Department
Personal name
Funding Source
Organization
Seirei Mikatahara General Hospital, Department of Rehabilitation Medicine
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
Seirei Mikatahara General Hospital
Address
3453, Mikatahara-cho, Hamamatsu City, Shizuoka Prefecture
Tel
053-436-1251
dependonhero@yahoo.co.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
| 2022 | Year | 02 | Month | 17 | Day |
Related information
URL releasing protocol
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201902237347483549
Publication of results
Unpublished
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201902237347483549
Number of participants that the trial has enrolled
333
Results
In total, 333 consecutive patients with aspiration pneumonitis were screened for eligibility, of whom 276 (82.9%) were recruited for the study.
There were 231 survivors and 45 non-survivors. There were significant differences in 11 items in the comparison between the two groups.
Multivariate logistic regression model results showed that A-DROP score, GNRI score, and gender were independent early predictors of mortality.
Results date posted
| 2022 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients admitted to hospital with swallowing pneumonia
Participant flow
Patients were included in the study by being hospitalized. At Seirei Mikatahara General Hospital, we explained the unintended use of medical records at the time of the first visit using oral and written information. In this study, we only included patients in which informed consent was obtained for the unintended use of medical records.
Adverse events
None
Outcome measures
90-day survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 06 | Day |
Other
Other related information
Patient information of all patients hospitalized with aspiration pneumonia over a 1-year period was analyzed.
Management information
Registered date
| 2022 | Year | 02 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053535
