UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020112 |
|---|---|
| Receipt number | R000022770 |
| Scientific Title | Evaluation of plasma arginine vasopressin in hypertonic saline test in patients with diencephalohypophysial diseases |
| Date of disclosure of the study information | 2015/12/08 |
| Last modified on | 2021/06/10 19:54:32 |
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Basic information
Public title
Evaluation of plasma arginine vasopressin in hypertonic saline test in patients with diencephalohypophysial diseases
Acronym
Evaluation of plasma arginine vasopressin in hypertonic saline test in patients with diencephalohypophysial diseases
Scientific Title
Evaluation of plasma arginine vasopressin in hypertonic saline test in patients with diencephalohypophysial diseases
Scientific Title:Acronym
Evaluation of plasma arginine vasopressin in hypertonic saline test in patients with diencephalohypophysial diseases
Region
| Japan |
Condition
Condition
Diabetes insipidus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the reference range of plasma arginine vasopressin with AVP kit Yamasa.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma AVP in hypertonic saline test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Hypertonic saline test
5% salt solution, 6 mL/kg, intravenous drip infusion for 2 hours
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 diencephalohypophysial diseases
Key exclusion criteria
Patients suspected of having diabetes insipidus
(Serum Na concentration is not less than 147 mEq/L and daily urine volume is not less that 2000 mL)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Arima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2194
arima105@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takagi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2194
Homepage URL
htakagi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Diabetes, Nagoya Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Endocrinology and Diabetes, Nagoya Graduate School of 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
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-744-2973
ethics@med.nagoya-u.ac.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
| 2015 | Year | 12 | Month | 08 | 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
| 2016 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 06 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2021 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022770
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
