UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046436