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Trial registered on ANZCTR


Registration number
ACTRN12618001777280
Ethics application status
Approved
Date submitted
26/10/2018
Date registered
30/10/2018
Date last updated
30/10/2018
Date data sharing statement initially provided
30/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Relevance of novel urinary biomarkers of acute kidney injury in healthy volunteers: a prospective randomised crossover trial
Scientific title
Relevance of novel urinary biomarkers of acute kidney injury in healthy volunteers: a prospective randomised crossover trial
Secondary ID [1] 296430 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
The RUBI RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute kidney injury 310190 0
Condition category
Condition code
Renal and Urogenital 308939 308939 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to 'increase their fluid intak'e by consuming 1000ml of water orally above their usual daily fluid intake or to 'fluid restrict' from mid-night for 12 hours. Following a washout of 4 days participants will complete the crossover intervention by either 'fluid restrict' or 'increase their fluid intake'. Study investigators will remind participants of their allocated study arm prior to and during the invervention period, however adherence is not actively monitored.
Intervention code [1] 312760 0
Early detection / Screening
Comparator / control treatment
Participants are their own control which is consistent with the crossover design.
Control group
Active

Outcomes
Primary outcome [1] 307902 0
Urinary levels of Tissue inhibitor of metalloproteinase type 2 (TIMP-2)
Timepoint [1] 307902 0
12 hours from baseline
Primary outcome [2] 307912 0
Urinary levels of Insulin-like growth factor binding protein type 7 (IGFBP-7)
Timepoint [2] 307912 0
12=hours from baseline
Secondary outcome [1] 353278 0
Change in urinary creatinine concentration
Timepoint [1] 353278 0
Baseline, 12 hours and 24 hours following the intervention.
Secondary outcome [2] 353302 0
Urinary levels of Tissue inhibitor of metalloproteinase type 2 (TIMP-2)
Timepoint [2] 353302 0
24-hours from baseline
Secondary outcome [3] 353303 0
Urinary levels of Insulin-like growth factor binding protein type 7 (IGFBP-7)
Timepoint [3] 353303 0
24-hours from baseline

Eligibility
Key inclusion criteria
Aged 18 years or older
Employed in the Department of Intensive Care, Austin Hospital (Heidelberg, Victoria, Australia)
No known chronic kidney disease
Not currently receiving diuretic treatment
No known or suspected pregnancy
participant provides written prior consent to participant
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by the 'R" computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data will be analysed using the R Software for Statistical Computing. We will perform standard epidemiologic description of the studied population, by expressing median and quartiles ranges for quantitative variables, and count (percentage) for qualitative variables. A p value < 0.05 will be considered as evidence of statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12272 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 24463 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301032 0
Hospital
Name [1] 301032 0
Austin Hospital
Address [1] 301032 0
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 301032 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 300623 0
None
Name [1] 300623 0
Address [1] 300623 0
Country [1] 300623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301786 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 301786 0
145 Studley Road
Heidelberg
Victoria 3084
Ethics committee country [1] 301786 0
Australia
Date submitted for ethics approval [1] 301786 0
18/06/2018
Approval date [1] 301786 0
24/10/2018
Ethics approval number [1] 301786 0
LNR/18/Austin/295

Summary
Brief summary
Early detection of acute kidney injury in high-risk patients will enable clinicans to apply interventions to mitigate or prevent it early. Ten healthy adult volunteers will participate in this randomised crossover study. This study is evaluating the impact of hydration on urinary levels of two naturally occuring biomarkers with acute kidney injury. Participants will drink an additional 1000ml of water above their daily intake or fast from midnight for 12 hours. Urine samples will be tested at baseline, 12-hours and 24-hours to assess for changes in the urinary levels of these two biomarkers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88098 0
Prof Rinaldo Bellomo
Address 88098 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 88098 0
Australia
Phone 88098 0
+61394965992
Fax 88098 0
+61394963932
Email 88098 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 88099 0
Prof Rinaldo Bellomo
Address 88099 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 88099 0
Australia
Phone 88099 0
+61394965992
Fax 88099 0
+61394963932
Email 88099 0
rinaldo.bellomo@austin.org.au
Contact person for scientific queries
Name 88100 0
Dr Glenn Eastwood
Address 88100 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 88100 0
Australia
Phone 88100 0
+61394964835
Fax 88100 0
+61394963932
Email 88100 0
glenn.eastwood@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Undecided at this stage.
What supporting documents are/will be available?
Ethical approval
Attachments/websites
Type [1] 11 0
Ethical approval
URL/details/comments [1] 11 0
Summary results
Not applicable