UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041222 |
|---|---|
| Receipt number | R000046436 |
| Scientific Title | Nutritional management for patients with aspiration pneumonia |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2022/11/08 21:36:56 |
* 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
Nutritional management for patients with aspiration pneumonia
Acronym
Nutritional management for patients with aspiration pneumonia
Scientific Title
Nutritional management for patients with aspiration pneumonia
Scientific Title:Acronym
Nutritional management for patients with aspiration pneumonia
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Medicine in general | Pneumology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify nutritional management for patients with aspiration pneumonia in acute care hospitals and to investigate the association between the dose of nutrition during fasting period and clinical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In-hospital mortality
Key secondary outcomes
(1) Length of hospital stay
(2) Total oral intake at discharge
(3) Readmission
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
(1) Patients who were hospitalized for aspiration pneumonia from January 1, 2013 to December 31, 2018
(2) Patients aged 65 years or older
Key exclusion criteria
(1)Patients who received oral feeding on the day of admission
(2) Patients who received tube feeding on the day of admission
(3) Patients who died or were discharged within 7 days after admission
(4) Patients whose height is less than 100 cm or over 200 cm
(5) Patients whose body weight is less than 10 kg or over 200 kg
(6) Patients whose body weight or height data is missing
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Maeda |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Geriatric Medicine
Zip code
474-8511
Address
7-430 Morioka, Obu, Aichi, 474-8511, Japan
TEL
0562-46-2311
kskmaeda@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Kamoshita |
Organization
Otsuka Pharmaceutical Factory, Inc.
Division name
Medical Affairs Department
Zip code
101-0048
Address
2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo
TEL
03-5217-5954
Homepage URL
kamoshitas@otsuka.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Otsuka Pharmaceutical Factory, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Promotion Office Research and Medical Division Planning and Management Department
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture 474-8511, Japan
Tel
0562-46-2311
yaday@ncgg.go.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
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20457
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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
A cohort study using the medical claims database
Data source
A medical database provided by Medical Data Vision Co. Ltd. The database is based on the DPC data/medical and technical service claims data. The database covers about 20% of all DPC hospitals in Japan. All data is anonymized from the viewpoint of personal information protection.
Survey of nutritional management
The nutritional management are surveyed based on the prescription and treatment records available in the database. We analyze route of administration, dose of nutrition, risk factors for long-term fasting, and types of parenteral nutrition products.
Association between the dose of nutrition and clinical outcomes
Patients who are fasting more than 7 days, are divided into three or four groups based on their extracted nutritional records between days 1 and 7. To examine the association between the dose of nutrition and clinical outcomes, multivariable logistic regression analysis adjusting for patient characteristics as confounding factors is performed, and odds ratios and the 95% confidence intervals are estimated.
Management information
Registered date
| 2020 | Year | 07 | Month | 27 | Day |
Last modified on
| 2022 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046436
