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Trial registered on ANZCTR


Registration number
ACTRN12619000530123
Ethics application status
Approved
Date submitted
1/04/2019
Date registered
3/04/2019
Date last updated
3/04/2019
Date data sharing statement initially provided
3/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective observational pilot study into the renal effects of using dexmedetomidine for sedation in intensive care
Scientific title
A prospective observational pilot study into the renal effects of using dexmedetomidine for sedation in intensive care
Secondary ID [1] 297840 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedation 312214 0
Condition category
Condition code
Renal and Urogenital 310758 310758 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients in intensive care receiving dexmedetomidine sedation are observed for a 24 hour period. Arterial blood will be drawn from an existing arterial line and urine will be collected from an existing urinary catheter. This means there will not be any discomfort or inconvenience for the patient. The following samples will be collected:

• 1 ml blood in a safePICO Aspirator syringe
o for pH, pO2, pCO2 & lactate

• 4 ml blood in a lithium-heparin tube
o for metanephrines

• 4 ml blood in an EDTA tube
o for renin

• 2 ml blood in an EGTA tube containing glutathione
o for plasma noradrenaline

• 3 ml blood in an EDTA tube
o for serum cystatin C & plasma cytokines (tumour necrosis factor alpha, interleukin 6 & interleukin 10)

• 2 ml blood in a tube containing EDTA, reduced glutathione and butylated hydroxytoluene
o for plasma free F2-isoprostanes (non-esterified)

• 2 ml urine in a sterile container
o for neutrophil gelatinase-associated lipocalin and F2-isoprostanes

These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started. The total blood volume collected during the study will be 80 ml and the total urine volume will be 10 ml. We will also record the sodium, potassium and creatinine levels at the start and end of the study that are done daily on the ICU as part of routine care.

The continuous assessment of urinary oxygenation will be measured using an oxygen sensor probe developed by Oxford Optronix Ltd., 19-21 East Central, 127 Olympic Avenue, Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom. The sensor is inserted into the urinary catheter so that it remains within the catheter and does not exit the tip. This aims to avoid incorrect measurement of bladder wall oxygen tension instead of true urinary oxygen tension, and also means there will not be any discomfort for the patient. This would provide continuous measurements of the urinary oxygenation. This will be used as a surrogate marker of medullary tissue pO2 and thus, renal oxygenation.
Intervention code [1] 314076 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319606 0
The effect of dexmedetomidine on urinary pO2
Timepoint [1] 319606 0
The first 24 hours from the patient starting to receive dexmedetomidine
Secondary outcome [1] 368839 0
The effect of dexmedetomidine on blood pH
Timepoint [1] 368839 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [2] 368840 0
The effect of dexmedetomidine on blood pO2
Timepoint [2] 368840 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [3] 368841 0
The effect of dexmedetomidine on blood pCO2
Timepoint [3] 368841 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [4] 368842 0
The effect of dexmedetomidine blood lactate
Timepoint [4] 368842 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [5] 368843 0
The effect of dexmedetomidine on plasma sodium
Timepoint [5] 368843 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [6] 368844 0
The effect of dexmedetomidine on plasma potassium
Timepoint [6] 368844 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [7] 368845 0
The effect of dexmedetomidine on plasma creatinine
Timepoint [7] 368845 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [8] 368847 0
The effect of dexmedetomidine on plasma metanephrine
Timepoint [8] 368847 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [9] 368848 0
The effect of dexmedetomidine on plasma renin
Timepoint [9] 368848 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [10] 368849 0
The effect of dexmedetomidine on plasma noradrenaline
Timepoint [10] 368849 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [11] 368850 0
The effect of dexmedetomidine on urine neutrophil gelatinase-associated lipocalin (NGAL)
Timepoint [11] 368850 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [12] 368851 0
The effect of dexmedetomidine on serum cystatin C
Timepoint [12] 368851 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [13] 368852 0
The effect of dexmedetomidine on plasma tumour necrosis factor alpha
Timepoint [13] 368852 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [14] 368948 0
The effect of dexmedetomidine on plasma normetanephrine
Timepoint [14] 368948 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [15] 368949 0
The effect of dexmedetomidine on plasma interleukin 6
Timepoint [15] 368949 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.
Secondary outcome [16] 368950 0
The effect of dexmedetomidine on plasma interleukin 10
Timepoint [16] 368950 0
These samples will be collected prior to the patient receiving dexmedetomidine and at 2, 4, 8 and 24 hours after dexmedetomidine infusion has been started.

Eligibility
Key inclusion criteria
Patients will be eligible for participation if their treating doctor was already intending to start them on this treatment (dexmedetomidine) for an existing clinical indication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if aged less than 18 years, pregnant, or they have acute or chronic end stage kidney failure and are receiving renal replacement therapy.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
We plan to collect information from the monitor and transfer it to a statistics program to assess values obtained. We plan to use descriptive statistics and graph analysis to assess urinary oxygenation over time in these patients along with the method of generalized estimating equations to analyse the longitudinal data that we will collect. Our main interest will be the change from baseline within each participant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/04/2018
Date of last participant enrolment
Anticipated
Actual
31/12/2018
Date of last data collection
Anticipated
Actual
1/01/2019
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13522 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 26141 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 26142 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 302361 0
Hospital
Name [1] 302361 0
The Royal Melbourne Hospital ICU Research Fund
Country [1] 302361 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital ICU
Address
300 Grattan St
Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 302272 0
None
Name [1] 302272 0
Address [1] 302272 0
Country [1] 302272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303037 0
MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 303037 0
Ethics committee country [1] 303037 0
Australia
Date submitted for ethics approval [1] 303037 0
27/06/2017
Approval date [1] 303037 0
16/11/2017
Ethics approval number [1] 303037 0
LNR/17/MH/224

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

Contacts
Principal investigator
Name 92250 0
Dr Charlie Harding
Address 92250 0
The Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 92250 0
Australia
Phone 92250 0
+61 3 9342 9100
Fax 92250 0
Email 92250 0
Charlie.Harding@mh.org.au
Contact person for public queries
Name 92251 0
Charlie Harding
Address 92251 0
The Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 92251 0
Australia
Phone 92251 0
+61 3 9342 9100
Fax 92251 0
Email 92251 0
Charlie.Harding@mh.org.au
Contact person for scientific queries
Name 92252 0
Charlie Harding
Address 92252 0
The Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 92252 0
Australia
Phone 92252 0
+61 3 9342 9100
Fax 92252 0
Email 92252 0
Charlie.Harding@mh.org.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.