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Trial registered on ANZCTR
Registration number
ACTRN12619000590167
Ethics application status
Approved
Date submitted
10/04/2019
Date registered
16/04/2019
Date last updated
16/04/2019
Date data sharing statement initially provided
16/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A prospective study conducted in an adult intensive care unit to measure the breakdown products of citrate during kidney dialysis
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Scientific title
Citrate metabolism in critically ill patients receiving continuous renal replacement therapy using regional citrate anticoagulation
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Secondary ID [1]
297941
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Nil known
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Universal Trial Number (UTN)
U1111-1231-5078
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Trial acronym
CiMet
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute kidney failure
312331
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Condition category
Condition code
Renal and Urogenital
310894
310894
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0
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Kidney disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Regional citrate anticoagulation (RCA) is currently the preferred method of anticoagulating the extracorporeal circuit used in continuous renal replacement therapy (CRRT).
The citrate solution is infused into the blood before the filter and a residual amount circulates back into the patients bloodstream prior to metabolism by the liver.
At present, no consensus exists as to the ultimate metabolic fate of the infused citrate.
In this study, participants undergoing CRRT using RCA will have blood collected once before commencement of CRRT, then once a day for the duration of their CRRT or for five days, which ever occurs first and then once the day after cessation of their CRRT.
These samples will be analysed to ascertain both the plasma concentration of citrate as well as the potential metabolic products.
Participants will be monitored according to standard ICU protocols during treatment.
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Intervention code [1]
314163
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Measurement of potential products of citrate metabolism by serum assay.
The metabolites assessed will be triglycerides, cholesterol, beta-hydroxy butyrate, acetoacetate, pyruvate and L-lactate.
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Assessment method [1]
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Timepoint [1]
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Before commencing CRRT, once a day for five days or the duration of their treatment during CRRT and once the day after cessation of CRRT.
Measurements will be taken at 0600hrs each day.
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Secondary outcome [1]
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Tracking of the plasma concentration of citrate before, during and after CRRT. The citrate concentration will be analysed at the same time points as for other biochemical markers, that is, before commencing CRRT, once a day for five days or the duration of their treatment during CRRT and once the day after cessation of CRRT.
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Assessment method [1]
369273
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Timepoint [1]
369273
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Samples will be taken at 0600hrs each day.
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Eligibility
Key inclusion criteria
Clinical requirement for RCA CRRT in patients admitted to the Sunshine Coast University Hospital Intensive Care Unit.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Age under 18 years
Patients who are pregnant
Patients with a haemoglobin concentration less than 80 grams per litre
Patients with advanced liver disease (Childs C)
Patients likely to die within 24 hours of admission the ICU
Patients with known hyperlipidaemic states (eg: pancreatitis)
Patients taking lipid lowering drugs (eg: statins)
Known hypersensitivity or allergy to citrate compounds
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Statistical methods will be largely descriptive.
No formal power calculation was performed as the intention is to describe a single population rather than to discriminate between two populations.
Therefore, sample size was estimated from the number required to demonstrate a 25% rise in baseline triglyceride level.. On this basis, approximately 20 should be sufficient.
The data collected will be analysed to ascertain the plasma citrate and its potential metabolites (eg: triglycerides)
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2019
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Actual
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Date of last participant enrolment
Anticipated
30/06/2020
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Actual
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Date of last data collection
Anticipated
10/07/2020
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
13602
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Sunshine Coast University Hospital - Birtinya
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Recruitment postcode(s) [1]
26264
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4575 - Birtinya
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Funding & Sponsors
Funding source category [1]
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Other
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Name [1]
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Sunshine Coast Institute for Critical Care Research
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Address [1]
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PO Box 5340
Sunshine Coast Mail Centre
QLD 4560
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Country [1]
302455
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Australia
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Primary sponsor type
Hospital
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Name
Sunshine Coast University Hospital
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Address
PO Box 5340
Sunshine Coast Mail Centre
QLD 4560
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
302358
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Address [1]
302358
0
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Country [1]
302358
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303124
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The Prince Charles Hospital Human Research Ethics Committee
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Ethics committee address [1]
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Research, Ethics and Governance Office
The Prince Charles Hospital
Building 14
Rode Road
Chermside Q 4032
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Ethics committee country [1]
303124
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Australia
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Date submitted for ethics approval [1]
303124
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11/02/2019
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Approval date [1]
303124
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18/03/2019
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Ethics approval number [1]
303124
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HREC/2019/QPCH/45895
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Summary
Brief summary
The primary aim of the study is to quantify to plasma concentration of citrate metabolites (eg: triglycerides) when using RCA with CRRT.
We expect to establish a means and standard deviations for these plasma concentrations.
Our secondary aim is to track the concentration of citrate over time.
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Trial website
N/A
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Trial related presentations / publications
Nil
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Chris Anstey
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Address
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c/- Intensive Care Unit
Sunshine Coast University Hospital
6 Doherty Street
Birtinya
QLD 4575
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Country
92554
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Australia
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Phone
92554
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+61 7 5202 1552
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Fax
92554
0
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Email
92554
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[email protected]
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Contact person for public queries
Name
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A/Prof Chris Anstey
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Address
92555
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c/- Intensive Care Unit
Sunshine Coast University Hospital
6 Doherty Street
Birtinya
QLD 4575
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Country
92555
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Australia
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Phone
92555
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+61 7 5202 1552
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Fax
92555
0
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Email
92555
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[email protected]
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Contact person for scientific queries
Name
92556
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A/Prof Chris Anstey
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Address
92556
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c/- Intensive Care Unit
Sunshine Coast University Hospital
6 Doherty Street
Birtinya
QLD 4575
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Country
92556
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Australia
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Phone
92556
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+61 7 5202 1552
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Fax
92556
0
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Email
92556
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1840
Study protocol
377374-(Uploaded-10-04-2019-13-27-27)-Study-related document.docx
1841
Informed consent form
This form is for an adult participant providing hi...
[
More Details
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377374-(Uploaded-10-04-2019-13-28-42)-Study-related document.docx
1842
Informed consent form
This form is for a responsible person (eg: next of...
[
More Details
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377374-(Uploaded-10-04-2019-13-29-08)-Study-related document.docx
1843
Other
This is a post hoc information form, not a consent...
[
More Details
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377374-(Uploaded-10-04-2019-13-29-34)-Study-related document.docx
1844
Ethical approval
377374-(Uploaded-10-04-2019-13-29-59)-Study-related document.pdf
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.
Download to PDF