UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005344 |
|---|---|
| Receipt number | R000006350 |
| Scientific Title | Studies on the relationship between aspiration pneumonia and substance P in patients with ALS |
| Date of disclosure of the study information | 2011/03/30 |
| Last modified on | 2018/10/04 17:56:46 |
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Basic information
Public title
Studies on the relationship between aspiration pneumonia and substance P in patients with ALS
Acronym
Studies on the relationship between aspiration pneumonia and substance P in patients with ALS
Scientific Title
Studies on the relationship between aspiration pneumonia and substance P in patients with ALS
Scientific Title:Acronym
Studies on the relationship between aspiration pneumonia and substance P in patients with ALS
Region
| Japan |
Condition
Condition
ALS
Classification by specialty
| Pneumology | Neurology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to study the difference of substance P concentrations in patients with ALS complicated with or without aspiration pneumonia.
Basic objectives2
Others
Basic objectives -Others
In order to study the effects of substance P production and development of pneumonia in patients with ALS.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Concentrations of substance P, bacteria in oral cavity
Key secondary outcomes
Vital sign, development of pneumonia
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ALS
Key exclusion criteria
No
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuko Ohi |
Organization
National Hospital Organization Hachinohe National Hospital
Division name
Clinical Nursing Research Section
Zip code
Address
3-13-1 Fukiage, Hachinohe City, Aomori Prefecture, 031-0003, Japan
TEL
0178-45-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mutsuo Yamaya |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL
022-717-7184
Homepage URL
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
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立病院機構八戸病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 30 | 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
Results
During the observation period, patients
who received the oral care had
fewer febrile days and lower frequency of the development of pneumonia. Salivary concentration of substance P was higher in the patients received the oral care.
Geriatr Gerontol Int 13: 1082-1084, 2013.
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
| 2011 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 03 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 03 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 03 | Day |
Other
Other related information
During the observation period, patients
who received the oral care had
fewer febrile days and lower frequency of the development of pneumonia. Salivary concentration of substance P was higher in the patients received the oral care.
Geriatr Gerontol Int 13: 1082-1084, 2013.
Management information
Registered date
| 2011 | Year | 03 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006350
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
