UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effects of improvement of malnutrition on the prevention of pneumonia in bedridden patients
Acronym	Study on the effects of improvement of malnutrition on the prevention of pneumonia in bedridden patients
Scientific Title	Study on the effects of improvement of malnutrition on the prevention of pneumonia in bedridden patients
Scientific Title:Acronym	Study on the effects of improvement of malnutrition on the prevention of pneumonia in bedridden patients
Region	Japan

Condition
Condition	Pneumonia
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of improvement of malnutrition on the prevention of pneumonia in bedridden patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of pneumonia
Key secondary outcomes	serum albumin, body weight

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	bedridden patients
Key exclusion criteria	Patients judged inappropriate by physician
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Genichiro Middle name Last name Kawakami
Organization	National Hospital Organization Hachinohe National Hospital
Division name	Department of Internal Medicine
Zip code	031-0003
Address	3-13-1 Fukiage, Hachinohe City, Aomori Prefecture, 031-0003, Japan
TEL	0178-45-6111
Email	kawakami-2@hosp.go.jp

Public contact
Name of contact person	1st name Mutsuo Middle name Last name Yamaya
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Advanced Preventive Medicine for Infectious Disease
Zip code	980-8575
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Japan
TEL	0227177184
Homepage URL
Email	myamaya@med.tohoku.ac.jp

Sponsor
Institute	National Hospital Organization Hachinohe National Hospital
Institute
Department

Funding Source
Organization	National Hospital Organization Hachinohe National Hospital
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	Hachinohe National Hospital Ethics Committee
Address	3-13-1 Fukiage, Hachinohe City, Aomori Prefecture, 031-0003, Japan
Tel	0178-45-6111
Email	haga.keita.vn@mail.hosp.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	2018 Year 06 Month 19 Day

Related information
URL releasing protocol	https://www.naika.or.jp/english/
Publication of results	Published

Result
URL related to results and publications	https://www.naika.or.jp/english/
Number of participants that the trial has enrolled	68
Results	Of the analyzed patients, pneumonia developed in 52 (76%) patients, and the mean pneumonia frequency was 1.6 times per year during the first year of stay. After performing of nutritional treatments, frequency of pneumonia was reduced. Additionally, increases in the proportions of patients presenting a reduced frequency of pneumonia were correlated with increases in the proportions of patients presenting increased levels of serum levels of albumin and/or total protein.
Results date posted	2019 Year 12 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients who were admitted to Hachinohe National Hospital between October 2001 and September 2016.
Participant flow	Patients who were bedridden and received oral care and were admitted to Hachinohe National Hospital for two years or longer.
Adverse events	No
Outcome measures	Age, sex, BMI, white bold cell (WBC) in the peripheral venous blood, values of serum total protein and serum albumin, frequency of pneumonia.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 14 Day
Date of IRB	2018 Year 03 Month 27 Day
Anticipated trial start date	2018 Year 03 Month 30 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete	2019 Year 11 Month 30 Day
Date analysis concluded	2019 Year 11 Month 30 Day

Other
Other related information	We will examine the effects of improvement of malnutrition with tube-fed or IVH on the prevention of pneumonia in bedridden patients.

Management information
Registered date	2018 Year 06 Month 19 Day
Last modified on	2020 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037686