UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033051 |
|---|---|
| Receipt number | R000037686 |
| Scientific Title | Study on the effects of improvement of malnutrition on the prevention of pneumonia in bedridden patients |
| Date of disclosure of the study information | 2018/06/19 |
| Last modified on | 2020/12/20 15:40:46 |
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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
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
myamaya@med.tohoku.ac.jp
Sponsor or person
Institute
National Hospital Organization Hachinohe National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037686
