UMIN-CTR Clinical Trial

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	Open public recruiting
Date of protocol fixation	2020 Year 06 Month 01 Day
Date of IRB	2020 Year 08 Month 25 Day
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	2021 Year 07 Month 26 Day

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