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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040899
Receipt No. R000046683
Scientific Title Effects of managing the water-electrolyte balance by delivering the optimal minimum amount of water and sodium after subarachnoid hemorrhage
Date of disclosure of the study information 2020/08/01
Last modified on 2020/06/25

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Basic information
Public title Effects of managing the water-electrolyte balance by delivering the optimal minimum amount of water and sodium after subarachnoid hemorrhage
Acronym Effects of managing the water-electrolyte balance by delivering the optimal minimum amount of water and sodium after subarachnoid hemorrhage
Scientific Title Effects of managing the water-electrolyte balance by delivering the optimal minimum amount of water and sodium after subarachnoid hemorrhage
Scientific Title:Acronym Effects of managing the water-electrolyte balance by delivering the optimal minimum amount of water and sodium after subarachnoid hemorrhage
Region
Japan

Condition
Condition aneurysmal subarachnoid hemorrhage
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to demonstrate that the requisite amount of water and sodium, delivered separately on an as-needed basis, may improve post-aSAH outcomes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of modified Rankin Scale(mRS)0-2 at dischrge and 3 months later
Key secondary outcomes The rate of symptomatic vasospasm and shunt dependent hydrocephalus

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 For 14days after operation,we keep euvolemia by delivering maintenance fluid according to water balance.The serum sodium level is evaluated twice a day at 8-hour intervals.We calculate urinary sodium excretion using the equation: body weight (kg) x 0.6 x [the last recorded- minus the current serum sodium concentration (mEq/l)] divided by 17. To restore the normal serum sodium level, we deliver the calculated minimum amount of sodium chloride (salt) perorally or via the nasogastric tube.
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 The aSAH patients who took clipping or endovascular coil embolization within 72 hours of the insult
Key exclusion criteria 1.the patients with World Federation of Neurological Surgery (WFNS) grade 5
2.the patients with SAH caused by except ruptured aneurysm
3.the patients with neurological deficit by aSAH with hematoma
4.the patients with neurological deficit by surgical complications
5.the patients with more than mRS3 on admision
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Shikata
Organization Tokushima university
Division name department of neurosurgery
Zip code 770-0042
Address Kuramoto-cho, Tokushima
TEL +81-88-631-3111
Email shikata.eiji@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Shikata
Organization Tokushima university
Division name department of neurosurgery
Zip code 770-0042
Address Kuramoto-cho, Tokushima
TEL +81-88-631-3111
Homepage URL
Email shikata.eiji@tokushima-u.ac.jp

Sponsor
Institute Tokushima university
department of neurosurgery
Institute
Department

Funding Source
Organization Tokushima university
department of neurosurgery
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokushima university department of neurosurgery
Address Kuramoto-cho, Tokushima 770-0042, Japan
Tel +81-88-631-3111
Email shikata.eiji@tokushima-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
2020 Year 08 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
2020 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2024 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 25 Day
Last modified on
2020 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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