Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000045415
Ethics application status
Approved
Date submitted
11/01/2016
Date registered
19/01/2016
Date last updated
19/01/2016
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
Nil
Universal Trial Number (UTN)
U1111-1178-2864
Trial acronym
BEaRSS
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 years.
Pregnancy.
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
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/08/2013
Date of last participant enrolment
Anticipated
Actual
1/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
QLD
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
Country [1] 292652 0
Primary sponsor type
Hospital
Name
Nambour General Hospital
Address
PO Box 547
Nambour
Queensland
4560
Country
Australia
Secondary sponsor category [1] 291370 0
None
Name [1] 291370 0
None
Address [1] 291370 0
Country [1] 291370 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294126 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 294126 0
Ethics committee country [1] 294126 0
Australia
Date submitted for ethics approval [1] 294126 0
13/08/2012
Approval date [1] 294126 0
20/08/2012
Ethics approval number [1] 294126 0
HREC/12/QRBW/252

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 716 716 0 0
/AnzctrAttachments/369882(v18-01-2016-13-03-24)-BEaRSS Study Protocol.docx

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

No information has been provided regarding IPD availability


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 between Two Dilute Citrate Solutions (15 vs. 18 mmol/l) in Continuous Renal Replacement Therapy: The Base Excess and Renal Substitution Solution Study.2016https://dx.doi.org/10.1159/000446979
N.B. These documents automatically identified may not have been verified by the study sponsor.