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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
Scientific title
Citrate metabolism in critically ill patients receiving continuous renal replacement therapy using regional citrate anticoagulation
Secondary ID [1] 297941 0
Nil known
Universal Trial Number (UTN)
U1111-1231-5078
Trial acronym
CiMet
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney failure 312331 0
Condition category
Condition code
Renal and Urogenital 310894 310894 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
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.
Intervention code [1] 314163 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319715 0
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.
Timepoint [1] 319715 0
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.
Secondary outcome [1] 369273 0
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.
Timepoint [1] 369273 0
Samples will be taken at 0600hrs each day.

Eligibility
Key inclusion criteria
Clinical requirement for RCA CRRT in patients admitted to the Sunshine Coast University Hospital Intensive Care Unit.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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)

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)
QLD
Recruitment hospital [1] 13602 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 26264 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 302455 0
Other
Name [1] 302455 0
Sunshine Coast Institute for Critical Care Research
Address [1] 302455 0
PO Box 5340
Sunshine Coast Mail Centre
QLD 4560
Country [1] 302455 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast University Hospital
Address
PO Box 5340
Sunshine Coast Mail Centre
QLD 4560
Country
Australia
Secondary sponsor category [1] 302358 0
None
Name [1] 302358 0
Address [1] 302358 0
Country [1] 302358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303124 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 303124 0
Research, Ethics and Governance Office
The Prince Charles Hospital
Building 14
Rode Road
Chermside Q 4032
Ethics committee country [1] 303124 0
Australia
Date submitted for ethics approval [1] 303124 0
11/02/2019
Approval date [1] 303124 0
18/03/2019
Ethics approval number [1] 303124 0
HREC/2019/QPCH/45895

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.
Trial website
N/A
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 92554 0
A/Prof Chris Anstey
Address 92554 0
c/- Intensive Care Unit
Sunshine Coast University Hospital
6 Doherty Street
Birtinya
QLD 4575
Country 92554 0
Australia
Phone 92554 0
+61 7 5202 1552
Fax 92554 0
Email 92554 0
chris.anstey@health.qld.gov.au
Contact person for public queries
Name 92555 0
A/Prof Chris Anstey
Address 92555 0
c/- Intensive Care Unit
Sunshine Coast University Hospital
6 Doherty Street
Birtinya
QLD 4575
Country 92555 0
Australia
Phone 92555 0
+61 7 5202 1552
Fax 92555 0
Email 92555 0
chris.anstey@health.qld.gov.au
Contact person for scientific queries
Name 92556 0
A/Prof Chris Anstey
Address 92556 0
c/- Intensive Care Unit
Sunshine Coast University Hospital
6 Doherty Street
Birtinya
QLD 4575
Country 92556 0
Australia
Phone 92556 0
+61 7 5202 1552
Fax 92556 0
Email 92556 0
chris.anstey@health.qld.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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1840 0
Study protocol
Citation [1] 1840 0
Link [1] 1840 0
Email [1] 1840 0
Other [1] 1840 0
Type [2] 1841 0
Informed consent form
Citation [2] 1841 0
Link [2] 1841 0
Email [2] 1841 0
Other [2] 1841 0
This form is for an adult participant providing his or her own consent
Type [3] 1842 0
Informed consent form
Citation [3] 1842 0
Link [3] 1842 0
Email [3] 1842 0
Other [3] 1842 0
This form is for a responsible person (eg: next of kin) to provide consent in the event that the adult participant can not provide his or her own consent
Type [4] 1843 0
Other
Citation [4] 1843 0
Link [4] 1843 0
Email [4] 1843 0
Other [4] 1843 0
This is a post hoc information form, not a consent form.
Type [5] 1844 0
Ethical approval
Citation [5] 1844 0
Link [5] 1844 0
Email [5] 1844 0
Other [5] 1844 0
Summary results
No Results