Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000999730
Ethics application status
Not yet submitted
Date submitted
6/09/2013
Date registered
10/09/2013
Date last updated
10/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Sodium control in aneurysmal subarachnoid haemorrhage
Scientific title
The effect of fludrocortisone plus standard care on sodium control in aneurysmal subarachnoid haemorrhage
Secondary ID [1] 283157 0
nil
Universal Trial Number (UTN)
U1111-1147-6570
Trial acronym
Sodium control in SAH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyponatraemia in subarachnoid haemorrhage 290013 0
Condition category
Condition code
Metabolic and Endocrine 290396 290396 0 0
Other metabolic disorders
Stroke 290410 290410 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fludrocortisone 100mcg oral tablet twice daily in addition to standard care until hyponatremia resolves per twice daily serum electrolytes
Adherence ensured by tablets being administered by nursing staff on hospital ward
Intervention code [1] 287889 0
Treatment: Drugs
Comparator / control treatment
Comparator is standard medical care:
intravenous fluid, and possibly oral fluid restriction and/or intravenous hypertonic saline
Control group
Active

Outcomes
Primary outcome [1] 290419 0
Sodium nadir by twice daily serum electrolytes
Timepoint [1] 290419 0
Day 1-18 post aneurysmal subarachnoid haemorrhage
Secondary outcome [1] 304477 0
Duration sodium <135mmol/L according to twice daily serum electrolytes
Timepoint [1] 304477 0
Day 1-18 post subarachnoid haemorrhage
Secondary outcome [2] 304478 0
Duration and intensity of oral fluid restriction, according to mL oral fluid consumed daily
Timepoint [2] 304478 0
Day 1-18 post aneurysmal subarachnoid haemorrhage
Secondary outcome [3] 304479 0
Duration and intensity of hypertonic saline delivery, according to mL hypertonic saline delivered daily
Timepoint [3] 304479 0
Day 1-18 post subarachnoid haemorrhage

Eligibility
Key inclusion criteria
Inclusion:
* D1-18 aneurysmal SAH
* Serum Na <135mmol/L
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:
* Thyroid abnormality
* Cortisol abnormality
* Pre-morbid cardiopulmonary disease
* Pre-morbid electrolyte imbalance
* Pre-morbid treated hypertension
* Pre-morbid systemic fungal infection
* Women who are pregnant
* Children and/or young people (<18 years)
* Aged (>80 years)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1488 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 7324 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 287909 0
Self funded/Unfunded
Name [1] 287909 0
Unfunded
Country [1] 287909 0
Primary sponsor type
Individual
Name
Dr Stephanie Teasdale
Address
Department of Diabetes and Endocrinology, Princess Alexandra Hospital
25 Manson Pde
Yeronga
Qld 4104
Country
Australia
Secondary sponsor category [1] 286638 0
None
Name [1] 286638 0
N/A
Address [1] 286638 0
N/A
Country [1] 286638 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289844 0
Metro South Human Research Ethics Committee (EC00167)
Ethics committee address [1] 289844 0
Centres for Health Research
Level 7 TRI
37 Kent Street WOOLLOONGABBA QLD 4102
Ethics committee country [1] 289844 0
Australia
Date submitted for ethics approval [1] 289844 0
19/09/2013
Approval date [1] 289844 0
Ethics approval number [1] 289844 0

Summary
Brief summary
Hyponatremia, which describes low blood sodium levels, occurs frequently in patients who are in the hospital after aneurysmal subarachnoid haemorrhage, a condition where there has been bleeding in the brain. Hyponatremia can cause confusion and seizures, and possibly long term effects on a patient’s ability to function. A substantial amount of resources are used in treating this condition.
This study looks at determining whether a medication called fludrocortisone can help in reducing the severity and duration of hyponatremia in this setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42722 0
Dr Stephanie Teasdale
Address 42722 0
Endocrine registrar, Department of Diabetes and Endocrinology at PA Hospital
25 Manson Pde
Yeronga
Qld 4104
Country 42722 0
Australia
Phone 42722 0
+61438336950
Fax 42722 0
Email 42722 0
[email protected]
Contact person for public queries
Name 42723 0
Dr Stephanie Teasdale
Address 42723 0
Dept of Diabetes and Endocrinology
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba
Qld 4102
Country 42723 0
Australia
Phone 42723 0
+61731762111
Fax 42723 0
Email 42723 0
[email protected]
Contact person for scientific queries
Name 42724 0
Dr Stephanie Teasdale
Address 42724 0
Department of Diabetes and Endocrinology, PA Hospital
25 Manson Pde
Yeronga
Qld
4104
Country 42724 0
Australia
Phone 42724 0
+61438336950
Fax 42724 0
Email 42724 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.