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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomised study conducted in an adult intensive care unit to compare the biochemical and acid-base effects of two solutions used during continuous renal replacement therapy (CRRT).
Scientific title
Biochemical and acid-base effects of two predilution haemofiltration solutions containing different concentrations of trisodium citrate, in critically ill patients undergoing continuous renal replacement therapy.
Secondary ID [1] 288271 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney failure 297222 0
Condition category
Condition code
Renal and Urogenital 297425 297425 0 0
Kidney disease

Study type
Description of intervention(s) / exposure
Continuous veno-venous haemofiltration (CVVHF) using a new predilution haemofiltration solution containing 15mmol/L of trisodium citrate as the anticoagulant.

CVVHF is conducted routinely in the Intensive Care Unit (ICU) when patients with critical illness require kidney support. The treatment regime lasts, on average, about five days though there is considerable variation in length of treatment. The patients are usually simultaneously undergoing some type of ventilatory support.

Blood samples are routinely taken on at least a daily basis whilst the patients are receiving CVVHF.

The occurrence of adverse events is monitored and if noted, dealt with in a timely and appropriate manner.
Intervention code [1] 293562 0
Treatment: Devices
Intervention code [2] 293607 0
Treatment: Other
Comparator / control treatment
The control group will use the standard 18mmol/L trisodium citrate haemofiltration solution as predilution during continuous veno-venous haemofiltration.
Control group

Primary outcome [1] 296984 0
The difference in standard base excess between the two groups being studied.
The SBE forms part of the normal blood gas report and the numerical result for the SBE was recorded from the serial arterial blood gas analyses taken as part of the routine care of all ICU patients.
Timepoint [1] 296984 0
Standard base excess was compared between the two groups on enrolment and on day 3 and day 5 of CRRT treatment.
Secondary outcome [1] 319805 0
Mortality rate between the two groups.
This outcome was assessed by chart audit.
Timepoint [1] 319805 0
On discharge from the ICU.

Key inclusion criteria
Non-pregnant adult patients who require extracorporeal support for acute kidney failure while being treated in an intensive care unit (ICU).
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Age under 18 years.
Weight > 100kgs
Advanced hepatic disease
Predicted to die within 24 hours of admission to the ICU
Allergy/hypersensitivity to citrate compounds.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked design
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
A previous retrospective audit had identified a rise in SBE to approximately 7.0meq/L (SD 3.5meq/L) by day 5 in patients receiving CVVHF using C18 anticoagulation compared to a mean rise to 3.5meq/L (SD 3.5meq/L) in patients receiving CVVHF using non-citrate anticoagulation (heparin). Assuming a power of 0.80, a level of significance of 0.05 and a 20% dropout rate in a two-sided experiment, gave a total of 2x25 (50) patients required to detect a difference in SBE between the groups of 3.5meq/L.

Continuous parametric data were compared using the Student t-test and reported as mean and standard deviation (SD). Non-parametric data were compared using the Mann-Whitney test and reported as median and interquartile range (IQR). Categorical and proportionate data were compared using a chi-square test for proportions. Where required, normality was checked using a Shapiro-Wilk test.

A longitudinal and correlated regression analysis was performed where time based repeated measures were encountered.

Time to event data were modelled using Cox regression whilst factors specifically influencing mortality were modelled using logistic regression.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 5005 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 12501 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 292652 0
Self funded/Unfunded
Name [1] 292652 0
Not applicable
Address [1] 292652 0
Not applicable
Country [1] 292652 0
Primary sponsor type
Nambour General Hospital
PO Box 547
Secondary sponsor category [1] 291370 0
Name [1] 291370 0
Address [1] 291370 0
Country [1] 291370 0

Ethics approval
Ethics application status
Ethics committee name [1] 294126 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 294126 0
Metro North Hospital and Health Service
Ethics committee country [1] 294126 0
Date submitted for ethics approval [1] 294126 0
Approval date [1] 294126 0
Ethics approval number [1] 294126 0

Brief summary
The primary aim of this study is to examine the association between the citrate concentration in haemofiltration fluid and the resulting Standard Base Excess (SBE) after several days of CVVHF.

We expect to confirm that performing CVVHF using a relatively high citrate concentration HF (18.0mmol/l) results in an elevation of SBE. We expect to show that using a lower citrate concentration HF (15.0mmol/l) results in much less elevation of SBE.

We also expect to show that use of the lower citrate concentration HF results in an acceptable filter life.
Trial website
Trial related presentations / publications
Results were presented at the local Nambour General Hospital Research Forum in September 2015. No citation or abstract is available.

Results were presented at the European Society of Intensive Care Medicine conference in Berlin, Germany in November 2015.

Anstey CM, Richardson AC, Campbell VK
A comparison between 2 dilute citrate solutions (15mmol/l vs 18 mmol/l) in continuous renal replacement therapy: the base excess and renal replacement solution (BEARRS) study
Intensive Care Medicine (Experimental) 2015; 3: A842

A manuscript suitable for publication has been drafted and is awaiting final proofing prior to submission for peer review.
Public notes

Principal investigator
Name 62586 0
Dr Chris Anstey
Address 62586 0
c/- Intensive Care Unit
Nambour General Hospital
PO Box 547
Queensland 4560
Country 62586 0
Phone 62586 0
+617 5470 6780
Fax 62586 0
+617 5470 6841
Email 62586 0
Contact person for public queries
Name 62587 0
Dr Chris Anstey
Address 62587 0
c/- Intensive Care Unit
Nambour General Hospital
PO Box 547
Queensland 4560
Country 62587 0
Phone 62587 0
+617 5470 6780
Fax 62587 0
+617 5470 6841
Email 62587 0
Contact person for scientific queries
Name 62588 0
Dr Chris Anstey
Address 62588 0
c/- Intensive Care Unit
Nambour General Hospital
PO Box 547
Queensland 4560
Country 62588 0
Phone 62588 0
+617 5470 6780
Fax 62588 0
+617 5470 6841
Email 62588 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary