Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000341224
Ethics application status
Approved
Date submitted
20/02/2018
Date registered
6/03/2018
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Are point-of-care albumin/creatinine measurements accurate in critically ill patients?
Scientific title
Are point-of-care urine albumin/creatinine measurements accurate in critically ill patients when compared to laboratory analysis.
Secondary ID [1] 294104 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 306695 0
Condition category
Condition code
Renal and Urogenital 305794 305794 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Enrolled patients will have 5ml of urine taken from the in situ catheter and analyzed on the point-of-care analyzer and sent for labratory analysis at SA pathology. Urine samples will be taken by a trained clinical researcher, whom is also trained and efficient with the point-of-care analyser being used.
Intervention code [1] 300382 0
Early Detection / Screening
Comparator / control treatment
Central laboratory analysis of urine albumin/creatinine.
Control group
Active

Outcomes
Primary outcome [1] 304860 0
The primary outcome is measurement of agreement between the POC analyser and laboratory analysis of albumin/creatinine measurements,

Agreement between measures will be analysed by Lin’s concordance correlation coefficient with Bland-Altman plots including 95% confidence limits of agreement. References 1 and 2.

1. Lin, L. I-K. 1989. A concordance correlation coefficient to evaluate reproducibility. Biometrics 45: 255-268.
2. Bland, J. M., and D. G. Altman. 1986. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet I: 307-310.
Timepoint [1] 304860 0
The timepoint of the primary outcome is the time at which a urine sample is taken for albumin/creatinine analysis.
Secondary outcome [1] 343397 0
The secondary outcome is a composite outcome to determine feasibility of using the POC analyser for routine use in the ICU setting. This will be determined by time efficiency and frequency of errors. Time efficiency will be calculated by reporting the time from urine sample acquisition to the POC result read out and by reporting the time from sending the urine sample to the central laboratory to time of reporting. The frequency of errors will be determined by the occurrence of errors resulting in no result readout. These errors are displayed as specific codes referring to a potential cause on the analyser screen.
Timepoint [1] 343397 0
At time of albumin/creatinine analysis following patient admission to ICU.

Eligibility
Key inclusion criteria
• >18 years of age
• Arterial line in situ
• Catheter in situ
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are conditions which affect albumin/creatinine results including patients with anuria or haematuria; pre-existing chronic kidney disease (as defined by an abnormal creatinine on previous testing if available); pre-existing diabetes mellitus; known proteinuria due to renal or post-renal causes and urinary tract infection.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Measurement of agreement will be assessed by Lin’s concordance correlation coefficient, Bland-Altman 95% limits of agreement and classification by Cohen’s kappa statistic. Other data will be presented as mean (Standard Deviation) or median [Interquartile range].

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2018
Actual
4/04/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
25/05/2018
Date of last data collection
Anticipated
Actual
25/05/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10071 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 21596 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 298741 0
Hospital
Name [1] 298741 0
Intensive Care Unit Research Department, Royal Adelaide Hospital
Country [1] 298741 0
Australia
Primary sponsor type
Individual
Name
Luke Weinel
Address
The Royal Adelaide Hospital, Port Road, Adelaide, 5000, South Australia, Australia.
Country
Australia
Secondary sponsor category [1] 297913 0
None
Name [1] 297913 0
Address [1] 297913 0
Country [1] 297913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299680 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 299680 0
Ethics committee country [1] 299680 0
Australia
Date submitted for ethics approval [1] 299680 0
05/03/2018
Approval date [1] 299680 0
09/03/2018
Ethics approval number [1] 299680 0
HREC/18/CALHN/141

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81270 0
Mr Luke Weinel
Address 81270 0
Royal Adelaide Hospital, Port Road, 5000, Adelaide, South Australia, Australia
Country 81270 0
Australia
Phone 81270 0
+61 8 707 41764
Fax 81270 0
Email 81270 0
luke.weinel@sa.gov.au
Contact person for public queries
Name 81271 0
Luke Weinel
Address 81271 0
Royal Adelaide Hospital, Port Road, 5000, Adelaide, South Australia, Australia
Country 81271 0
Australia
Phone 81271 0
+61 8 707 41764
Fax 81271 0
Email 81271 0
luke.weinel@sa.gov.au
Contact person for scientific queries
Name 81272 0
Luke Weinel
Address 81272 0
Royal Adelaide Hospital, Port Road, 5000, Adelaide, South Australia, Australia
Country 81272 0
Australia
Phone 81272 0
+61 8 707 41764
Fax 81272 0
Email 81272 0
luke.weinel@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.