Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000704695
Ethics application status
Approved
Date submitted
17/06/2014
Date registered
3/07/2014
Date last updated
3/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Correlation between glycated haemoglobin (HbA1c) and length of stay in hospital in total hip and knee replacements: A prospective observational cohort study
Scientific title
Correlation between glycated haemoglobin (HbA1c) and length of stay in hospital in total hip and knee replacements
Secondary ID [1] 284883 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Nil known
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elevated HbA1c 292196 0
Condition category
Condition code
Metabolic and Endocrine 292534 292534 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Weeks
Description of intervention(s) / exposure
HbA1c to be added test to standard preoperative pathology. Correlation of HbA1c level to length of stay recorded by observation.
Intervention code [1] 289606 0
Not applicable
Comparator / control treatment
Not applicable. Correlation study between HbA1c level and length of stay.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292396 0
Is there a statistically significant correlation between HbA1c level and length of stay in hospital following primary elective total hip or total knee replacement? HbA1c is tested by blood assay.
Timepoint [1] 292396 0
From day 1 at pre admission clinic until discharge from hospital
Secondary outcome [1] 308862 0
Correlation between HbA1c and length of stay while accounting for age, BMI and gender.
Timepoint [1] 308862 0
From day 1 at pre admission clinic until discharge from hospital

Eligibility
Key inclusion criteria
Undergoing primary elective unilateral total hip or knee replacement at Mackay Base Hospital
Over 18 years old
Competent to consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years old
Unable to provide consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Primary analysis by two-tailed bivariate correlation of HbA1c with length of stay using a Pearsons product-moment correlation coefficient as both variables are interval type. Using an Alpha error of 0.05, a Beta error of 0.95, and a correlation coefficient of 0.5, sample size was calculated at 38 participants in each of the total knee and total hip arms of the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2014
Actual
Date of last participant enrolment
Anticipated
25/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2639 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 8296 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 289427 0
Charities/Societies/Foundations
Name [1] 289427 0
Private Practice Trust Fund
Country [1] 289427 0
Australia
Primary sponsor type
Individual
Name
Marlow Coates
Address
Mackay Base Hospital
475 Bridge Road, Mackay, QLD, 4740
or
PO Box 5580, Mackay MC, QLD, 4741
Country
Australia
Secondary sponsor category [1] 288188 0
None
Name [1] 288188 0
Address [1] 288188 0
Country [1] 288188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291184 0
Human Resources Ethics Committee, Townsville Hospital and Health Service
Ethics committee address [1] 291184 0
Groundfloor of the Medilink Building
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Ethics committee country [1] 291184 0
Australia
Date submitted for ethics approval [1] 291184 0
21/03/2014
Approval date [1] 291184 0
02/06/2014
Ethics approval number [1] 291184 0
HREC/14/QTHS/75

Summary
Brief summary
The main focus of this project is to identify whether a correlation exists between HbA1c levels and the hospital length of stay (LOS) following total hip or total knee replacements at Mackay Base Hospital. Elevated HbA1c blood levels are an indication of poor glucose control over the preceding months and are used as a surrogate marker to predict micro and macro vascular complications in diabetics. We aim to measure HbA1c in all patients within our cohort, and look for a statistically significant correlation with LOS. The practical implication if a positive correlation is established is that improvement of HbA1c with lifestyle and medication prior to major elective surgery such as lower limb total arthroplasty, may significantly lower the cost burden upon the health system by reducing LOS. Research is limited and conflicting in this area, and further elucidation of a correlation would advance understanding and guide further research.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 88 88 0 0
/AnzctrAttachments/366550-HREC Approval Letter.pdf

Contacts
Principal investigator
Name 49258 0
Dr Marlow Coates
Address 49258 0
Mackay Base Hospital
475 Bridge Road, Mackay, QLD, 4740
or
PO Box 5580, Mackay MC, QLD, 4741
Country 49258 0
Australia
Phone 49258 0
+61 7 48856000
Fax 49258 0
Email 49258 0
marlow_coates@yahoo.com.au
Contact person for public queries
Name 49259 0
Dr Marlow Coates
Address 49259 0
Mackay Base Hospital
475 Bridge Road, Mackay, QLD, 4740
or
PO Box 5580, Mackay MC, QLD, 4741
Country 49259 0
Australia
Phone 49259 0
+61 7 48856000
Fax 49259 0
Email 49259 0
marlow_coates@yahoo.com.au
Contact person for scientific queries
Name 49260 0
Dr Marlow Coates
Address 49260 0
Mackay Base Hospital
475 Bridge Road, Mackay, QLD, 4740
or
PO Box 5580, Mackay MC, QLD, 4741
Country 49260 0
Australia
Phone 49260 0
+61 7 48856000
Fax 49260 0
Email 49260 0
marlow_coates@yahoo.com.au

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
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