Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000533493
Ethics application status
Approved
Date submitted
29/06/2007
Date registered
17/10/2007
Date last updated
17/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hydration following acute stroke
Scientific title
An investigation into the hydration status of acute stroke patients receiving thickened versus thin fluids
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Stroke 2470 0
Condition category
Condition code
Stroke 2266 2266 0 0
Haemorrhagic
Stroke 2571 2571 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a cross sectional study of acute stroke patients in which fluid intake will be recorded over a 24 hour period and hydration status will be assessed by measuring the urine specific gravity (USG) of a collected urine sample. Routine blood tests will also be accessed to determine biochemical indices of hydration. All tests will be performed over a 48 hour period for each patients.
Intervention code [1] 2111 0
Not applicable
Comparator / control treatment
There is no control group in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3476 0
Hydration status
Timepoint [1] 3476 0
1 measurement performed per patient within 14 days of admission.
Secondary outcome [1] 5798 0
Cognition via Mini Mental State Examination (MMSE), mobility via Barthel Score and rehab capacity via engagement in therapy.
Timepoint [1] 5798 0
Each of these 3 secondary outcome measures will be performed per patient within 14 days of admission.

Eligibility
Key inclusion criteria
Patients admitted to Flinders Medical Centre with clinical diagnosis of a stroke of all types (ischaemic/haemorrhagic). Patient or carer able to provide informed consent.
Minimum age
50 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have had a transient ischaemic attack (TIA), are nil by mouth, or have chronic renal impairment.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 463 0
5042

Funding & Sponsors
Funding source category [1] 2715 0
Hospital
Name [1] 2715 0
Nutrition & Dietetics Department, Flinders Medical Centre
Country [1] 2715 0
Australia
Primary sponsor type
Hospital
Name
Nutrition & Dietetics Department, Flinders Medical Centre
Address
Flinders Medical Centre
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 2460 0
None
Name [1] 2460 0
Address [1] 2460 0
Country [1] 2460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4635 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 4635 0
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 4635 0
Australia
Date submitted for ethics approval [1] 4635 0
Approval date [1] 4635 0
02/07/2007
Ethics approval number [1] 4635 0
222/067

Summary
Brief summary
This 7 week cross sectional study aims to get a 'snap shot' of the hydration status of stroke patients admitted to Flinders Medical Centre and the determine any significant differences in the hydration status and fluid intake between those receiving thickened fluids compared with stroke patients on thin fluids. This project also seeks to determine whether there are any associations between hydration status and rehabilitation outcomes post acute stroke. This will provide data to ascertain whether dehydration is a common phenomenon among acute stroke patients admitted to flinders medical centre and whether urine specific gravity is used in clinical practice to determine if stroke patients are dehydrated, and therefore, require additional fluid subcutaneously or intravenously to ensure adequate hydration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27676 0
Address 27676 0
Country 27676 0
Phone 27676 0
Fax 27676 0
Email 27676 0
Contact person for public queries
Name 11051 0
Olivia Warnes
Address 11051 0
Nutrition & Dietetics Department
Flinders Medical Centre
Bedford Park SA 5042
Country 11051 0
Australia
Phone 11051 0
+61 8 82044302
Fax 11051 0
+61 8 82044570
Email 11051 0
[email protected]
Contact person for scientific queries
Name 1979 0
Olivia Warnes
Address 1979 0
Nutrition & Dietetics Department
Flinders Medical Centre
Bedford Park SA 5042
Country 1979 0
Australia
Phone 1979 0
+61 8 82044302
Fax 1979 0
+61 8 82044570
Email 1979 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.