UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018417 |
|---|---|
| Receipt number | R000017700 |
| Scientific Title | Examination of the hydration effect with the oral rehydration water |
| Date of disclosure of the study information | 2015/07/24 |
| Last modified on | 2015/07/27 14:51:43 |
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Basic information
Public title
Examination of the hydration effect with the oral rehydration water
Acronym
Examination of the hydration effect with the oral rehydration water
Scientific Title
Examination of the hydration effect with the oral rehydration water
Scientific Title:Acronym
Examination of the hydration effect with the oral rehydration water
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Operative medicine | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A purpose of this study is to clarify a hydration effect with the oral rehydration water that assumed preoperation by comparison with the peripheral vein infusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
Before and after of the oral rehydration water
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
fasting-> wash out period-> drinking-oral rehydration solution-> intravenous drip
Interventions/Control_2
fasting-> wash out period-> fasting-> intravenous drip
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The person that I made a medical examination before an examination, and abnormality was not recognized
Key exclusion criteria
Person having diabetes.
Person having the disease of the cardiovascular system.
Person having hyperthyroidism.
Person having a severe liver function disorder, renal function disorder.
The person who judged that the medical attendant of this study was inappropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yokoyama |
Organization
Kyushu university
Division name
Dental anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6480
yokoyama@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Fujiwara |
Organization
Kyushu university
Division name
Dental anesthesiology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6480
Homepage URL
fujiwara@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university, Department of dental anesthesiology
Institute
Department
Personal name
Funding Source
Organization
self-sustaining
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 24 | Day |
Last modified on
| 2015 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017700
