UMIN-CTR Clinical Trial

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

aspiration pneumonia

Classification by specialty

Medicine in general	Pneumology	Geriatrics

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

In-hospital mortality

Key secondary outcomes

(1) Length of hospital stay
(2) Total oral intake at discharge
(3) Readmission

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Factory, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Otsuka Pharmaceutical Factory, Inc.

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 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.

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