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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041222
Receipt No. R000046436
Scientific Title Nutritional management for patients with aspiration pneumonia
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/27

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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
Email 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
Email kamoshitas@otsuka.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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 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 Preinitiation
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
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046436

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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