UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040899 |
|---|---|
| Receipt number | 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 | 2021/07/26 10:42:36 |
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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
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
shikata.eiji@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university
department of neurosurgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046683
