Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000070730
Ethics application status
Not yet submitted
Date submitted
17/01/2013
Date registered
18/01/2013
Date last updated
18/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin D in critically ill patients with sepsis in Central Australia
Scientific title
Measuring Vitamin D levels in patients admitted with sepsis and non sepsis in Central Australia to see if there is any difference in Vitamin D levels in these two groups
Secondary ID [1] 281789 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypovitaminosis D 288112 0
Sepsis 288113 0
Condition category
Condition code
Metabolic and Endocrine 288487 288487 0 0
Other metabolic disorders
Infection 288488 288488 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measuring Vitamin D level in patients admitted to Intensive care unit and High dependency unit.
Vitamin levels will be measured in blood samples taken on admission. It will be done once during patients admission.
Trial will commence from 1st March 2013 and continue till 31st December 2013
Intervention code [1] 286331 0
Not applicable
Comparator / control treatment
All patients admitted to ICU/ HDU
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288651 0
Incidence of hypovitaminosis D in critically ill patients.
Hypovitaminosis D is defined as Vitamin D levels in bloos samples less than 30ng/ml/
To see if there is any difference in vitamin D levels in septic and non-septic patients
Timepoint [1] 288651 0
baseline on admission to ICU/HDU
Secondary outcome [1] 300699 0
incidence of sepsis in patients admitted to ICU/HDU. This be assessed based on clinical assessment of patient along with blood results obtained from laboratory
Timepoint [1] 300699 0
with first 24 hrs of admission

Eligibility
Key inclusion criteria
all patients admitted to ICU/HDU and expected to stay for > 48hrs
> 18 yrs
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients expected to stay for < 48 hrs

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 425 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 6187 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 286576 0
Self funded/Unfunded
Name [1] 286576 0
Country [1] 286576 0
Primary sponsor type
Individual
Name
RAJENDRA GOUD
Address
PO Box:2234
Alice Springs Hospital
Alice Springs, NT-0870
Country
Australia
Secondary sponsor category [1] 285360 0
None
Name [1] 285360 0
none
Address [1] 285360 0
Country [1] 285360 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288645 0
Central Australian Human Research Ethics Committee
Ethics committee address [1] 288645 0
PO Box 4066
Alice Springs
NT 0871
Ethics committee country [1] 288645 0
Australia
Date submitted for ethics approval [1] 288645 0
28/01/2013
Approval date [1] 288645 0
Ethics approval number [1] 288645 0

Summary
Brief summary
Indigenous Australians comprise a major proportion of the Central Australia population and there are a number of issues relating to those requiring critical care for sepsis, including higher rates of bacteraemia and poorer socio-economic status compared with non-indigenous populations in Australia. Despite high sunlight exposure in this region, it is thought that a combination of factors is likely to contribute to lower vitamin D levels among this population. The study will aim to establish baseline vitamin D levels in critically ill patients with sepsis in a Central Australian population. Our hypothesis is that there will be a significant degree of vitamin D deficiency in the critically ill, particularly among the septic cohort, and that it may be so prevalent as to justify routine supplementation in all critically ill patients without prior screening, further down the track
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37102 0
Dr Rajendra Goud
Address 37102 0
PO Box:2234
Alice Springs Hospital
Alice Springs, NT-0870
Country 37102 0
Australia
Phone 37102 0
+61889517696
Fax 37102 0
Email 37102 0
[email protected]
Contact person for public queries
Name 37103 0
Dr Rajendra Goud
Address 37103 0
PO Box:2234
Alice Springs Hospital
Alice Springs, NT-0870
Country 37103 0
Australia
Phone 37103 0
+61889517696
Fax 37103 0
Email 37103 0
[email protected]
Contact person for scientific queries
Name 37104 0
Dr Rajendra Goud
Address 37104 0
Po Box: 2234
Alice Springs Hospital
Alice Springs, NT-0870
Country 37104 0
Australia
Phone 37104 0
+61889517696
Fax 37104 0
Email 37104 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.