UMIN-CTR Clinical Trial

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
Email	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
Email	dependonhero@yahoo.co.jp

Sponsor
Institute	Seirei Mikatahara General Hospital, Department of Rehabilitation Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053535