UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the usefulness of the measurement of plasma arginine vasopressin concentrations by LC-MS/MS method
Acronym	Evaluation of the usefulness of the measurement of plasma arginine vasopressin concentrations by LC-MS/MS method
Scientific Title	Evaluation of the usefulness of the measurement of plasma arginine vasopressin concentrations by LC-MS/MS method
Scientific Title:Acronym	Evaluation of the usefulness of the measurement of plasma arginine vasopressin concentrations by LC-MS/MS method
Region	Japan

Condition
Condition	Central diabetes insipidus, diencephalohypophysial diseases
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the usefulness of the measurement of plasma vasopressin concentration by LC-MS/MS method
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between plasma vasopressin concentrations measured by radioimmunoassay and those measured by LC-MS/MS method.
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	Device,equipment
Interventions/Control_1	Hypertonic saline infusion test
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 suspected to have central diabetes insipidus or diencephalohypophyseal diseases
Key exclusion criteria	Patients with hypernatremia (serum sodium concentration higher than or equal to 150 mEq/L)
Target sample size	30

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	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2142
Email	arima105@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Hagiwara
Organization	Nagoya University Hospital
Division name	Department of Endocrinology and Diabetes
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2142
Homepage URL
Email	d-hagiwarai@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	None
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, JAPAN
Tel	052-744-2973
Email	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	2021 Year 06 Month 01 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	Preinitiation
Date of protocol fixation	2021 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 15 Day
Last modified on	2021 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049116