Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000515493
Ethics application status
Approved
Date submitted
18/04/2016
Date registered
21/04/2016
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective study conducted in an adult intensive care unit to measure the plasma concentration of citrate during continuous renal replacement therapy.
Scientific title
Assessment of the plasma concentration of citrate in critically ill patients undergoing continuous renal replacement therapy.
Secondary ID [1] 289030 0
Nil
Universal Trial Number (UTN)
U1111-1182-0403
Trial acronym
ACCid HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney failure 298444 0
Condition category
Condition code
Renal and Urogenital 298542 298542 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, surrogate measures of questionable utility are used to assess the presence or otherwise of citrate toxicity.
In this study, participants undergoing CRRT using RCA will have blood and ultrafiltrate collected three times a day for the duration of their CRRT (approx. 7 days).
These samples will be analysed to ascertain the plasma concentration of citrate and the clearance of citrate across the haemofilter membrane.
Participants will be monitored in the usual way during treatment.
Intervention code [1] 294512 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298031 0
Quantification of plasma citrate concentration.
Timepoint [1] 298031 0
For the duration of CRRT.
Measurements will be taken at 0600hrs, 1400hrs and 2200hrs each day.
Secondary outcome [1] 322973 0
Serial assessment of citrate clearance across the haemofilter.
Clearance (C) will be calculated using the simultaneous values for ultrafiltrate concentration (U), plasma concentration (P) and ultrafiltrate flow rate (F) as C = UxF/P.
Timepoint [1] 322973 0
For the duration of the CRRT.
Ultrafiltrate will be sampled at the same times as the plasma samples are taken, that is, 0600hrs, 1400hrs and 2200hrs each day.

Eligibility
Key inclusion criteria
Clinical requirement for CRRT in patients admitted to the Intensive Care Unit (ICU).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 years
Patients who are pregnant
Patients with advanced liver disease (Childs C)
Patients likely to die within 24 hours of admission the the ICU
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 approximate a normal population distribution. A figure of 30 to 50 is generally agreed as sufficient.
The data collected will be analysed to ascertain the mean plasma citrate and its standard deviation.
To assess the utility of using clearance data to predict filter failure, These data will be analysed as a time-to-event series.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2017
Actual
28/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5636 0
Nambour General Hospital - Nambour
Recruitment hospital [2] 12693 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 13089 0
4560 - Nambour
Recruitment postcode(s) [2] 25115 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 293393 0
Other
Name [1] 293393 0
Sunshine Coast Institute for Critical Care Research
Country [1] 293393 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast University Hospital
Address
PO Box 5340
Sunshine Coast MC
QLD 4560
Country
Australia
Secondary sponsor category [1] 292221 0
None
Name [1] 292221 0
Address [1] 292221 0
Country [1] 292221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294850 0
Royal Brisbane and Womens Hospital HREC
Ethics committee address [1] 294850 0
Metro North Hospital and Health Service
Cnr Butterfield St and Bowen Bridge Road
Herston
Brisbane
QLD 4029
Ethics committee country [1] 294850 0
Australia
Date submitted for ethics approval [1] 294850 0
08/02/2016
Approval date [1] 294850 0
11/03/2016
Ethics approval number [1] 294850 0
HREC/16/QRBW/28

Summary
Brief summary
The primary aim of the study is to quantify to plasma concentration of citrate when using RCA with CRRT.
We expect to establish a mean and standard deviation for the plasma concentration.
Our secondary aim is to measure citrate clearance across the haemofilter over time.
We hope to show that this measure is sensitive enough to predict filter failure.
Trial website
N/A
Trial related presentations / publications
Nil.
Public notes
Attachments [1] 843 843 0 0
/AnzctrAttachments/370527-HREC Approval.pdf
Attachments [2] 844 844 0 0
/AnzctrAttachments/370527-Citrate Study Protocol v1.1 14 Jan 16.docx

Contacts
Principal investigator
Name 65166 0
Dr Chris Anstey
Address 65166 0
c/- Intensive Care Unit
Nambour General Hospital
SCHHS
PO Box 547
Nambour
QLD 4560
Country 65166 0
Australia
Phone 65166 0
+617 5470 6780
Fax 65166 0
+617 5470 6841
Email 65166 0
[email protected]
Contact person for public queries
Name 65167 0
Dr Chris Anstey
Address 65167 0
c/- Intensive Care Unit
Nambour General Hospital
SCHHS
PO Box 547
Nambour
QLD 4560
Country 65167 0
Australia
Phone 65167 0
+617 5470 6780
Fax 65167 0
+617 5470 6841
Email 65167 0
[email protected]
Contact person for scientific queries
Name 65168 0
Dr Chris Anstey
Address 65168 0
c/- Intensive Care Unit
Nambour General Hospital
SCHHS
PO Box 547
Nambour
QLD 4560
Country 65168 0
Australia
Phone 65168 0
+617 5470 6780
Fax 65168 0
+617 5470 6841
Email 65168 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseA Comparison of the Commonly Used Surrogate Markers for Citrate Accumulation and Toxicity during Continuous Renal Replacement Therapy with Regional Citrate Anticoagulation.2022https://dx.doi.org/10.1159/000524129
N.B. These documents automatically identified may not have been verified by the study sponsor.