ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypovitaminosis D

Sepsis

Condition category

Condition code

Metabolic and Endocrine

Other metabolic disorders

Infection

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]

Not applicable

Comparator / control treatment

All patients admitted to ICU/ HDU

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

baseline on admission to ICU/HDU

Secondary outcome [1]

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]

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?

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)

Recruitment hospital [1]

Alice Springs Hospital - Alice Springs

Recruitment postcode(s) [1]

0870 - Alice Springs

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

RAJENDRA GOUD

Address

PO Box:2234
Alice Springs Hospital
Alice Springs, NT-0870

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Central Australian Human Research Ethics Committee

Ethics committee address [1]

PO Box 4066
Alice Springs
NT 0871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/01/2013

Approval date [1]

Ethics approval number [1]

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

Dr Rajendra Goud

Address

PO Box:2234 Alice Springs Hospital Alice Springs, NT-0870

Country

Australia

Phone

+61889517696

Fax

[email protected]

Contact person for public queries

Name

Rajendra Goud

Address

PO Box:2234 Alice Springs Hospital Alice Springs, NT-0870

Country

Australia

Phone

+61889517696

Fax

[email protected]

Contact person for scientific queries

Name

Rajendra Goud

Address

Po Box: 2234 Alice Springs Hospital Alice Springs, NT-0870

Country

Australia

Phone

+61889517696

Fax

[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.

Trial Review

Documents added manually

Documents added automatically