Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001029785
Ethics application status
Approved
Date submitted
12/09/2013
Date registered
16/09/2013
Date last updated
12/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Calcium balance during citrate hemodialysis
Scientific title
Comparison of calcium mass balance with two different ionized calcium target ranges during hemodialysis with regional citrate anticoagulation
Secondary ID [1] 283212 0
None
Universal Trial Number (UTN)
U1111-1147-9668
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hemodialysis 290074 0
Kidney disease 290084 0
Condition category
Condition code
Renal and Urogenital 290456 290456 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single hemodialysis with regional citrate anticoagulation; target ionized calcium range 0.95 - 1.05 mmol/l
Intervention code [1] 287937 0
Treatment: Devices
Comparator / control treatment
Single hemodialysis with regional citrate anticoagulation; target ionized calcium range 1.1 - 1.2 mmol/l
Control group
Dose comparison

Outcomes
Primary outcome [1] 290482 0
calcium mass balance; calculated as (volume * concentration of calcium in infusion) - (spent dialysate volume * calcium concentration in dialysate); total calcium in dialysate measured with standard laboratory test
Timepoint [1] 290482 0
during hemodialysis
Secondary outcome [1] 304597 0
blood ionized calcium < 0.9 mmol/l; determined with point-of-care analyzer
Timepoint [1] 304597 0
during hemodialysis
Secondary outcome [2] 304598 0
change in intact parathiroid hormone (serrum assay)
Timepoint [2] 304598 0
during hemodialysis

Eligibility
Key inclusion criteria
adult patients, needing hemodialysis with regional citrate anticoagulation due to increased bleeding risk
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
known intolerance of citrate anticoagulation

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2013
Actual
14/01/2014
Date of last participant enrolment
Anticipated
Actual
12/01/2016
Date of last data collection
Anticipated
Actual
14/01/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 5409 0
Slovenia
State/province [1] 5409 0

Funding & Sponsors
Funding source category [1] 287957 0
Government body
Name [1] 287957 0
Javna agencija za raziskovalno dejavnost RS
Country [1] 287957 0
Slovenia
Primary sponsor type
Hospital
Name
University Medical Center Ljubljana, Dept. of Nephrology
Address
Zaloska 7
1000 LJubljana
Country
Slovenia
Secondary sponsor category [1] 286678 0
None
Name [1] 286678 0
Address [1] 286678 0
Country [1] 286678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289883 0
National medical ethics committee
Ethics committee address [1] 289883 0
prof. Joze Trontelj
Inst. za klinicno nevrofiziologijo
UKC Ljubljana
Zaloska 7
1000 LJubljana
Ethics committee country [1] 289883 0
Slovenia
Date submitted for ethics approval [1] 289883 0
04/03/2012
Approval date [1] 289883 0
19/03/2013
Ethics approval number [1] 289883 0

Summary
Brief summary
To compare calcium mass balance and effect on iPTH during regional citrate anticoagulation in hemodialysis with two different target ranges for ionized calcium
Trial website
Trial related presentations / publications
- Gubensek J, Orsag A, Ponikvar R, Buturovic-Ponikvar J. Calcium Mass Balance during Citrate Hemodialysis: A Randomized Controlled Trial Comparing Normal and Low Ionized Calcium Target Ranges. PLoS One. 2016 Dec 28;11(12):e0168593. doi: 10.1371/journal.pone.0168593
- J Gubensek, A Orsag, R Ponikvar, A Jerman and J Buturovic-Ponikvar. CALCIUM MASS BALANCE DURING CITRATE HEMODIALYSIS: A RANDOMIZED CONTROLLED TRIAL COMPARING NORMAL AND LOW IONIZED CALCIUM TARGET RANGE. Oral presentation at 53rd ERA-EDTA Congress, May 21st-24th, 2016, Vienna, Austria; Published in Nephrology Dialysis Transplantation Volume 31, Issue suppl 1, pp. i66-i67, doi: 10.1093/ndt/gfw145.03
Public notes

Contacts
Principal investigator
Name 42934 0
Dr Jakob Gubensek
Address 42934 0
University Medical Center Ljubljana
Dept. of Nephrology
Zaloska 7
1000 Ljubljana
Country 42934 0
Slovenia
Phone 42934 0
+386 1 522 3112
Fax 42934 0
Email 42934 0
[email protected]
Contact person for public queries
Name 42935 0
Dr Jakob Gubensek
Address 42935 0
University Medical Center Ljubljana
Dept. of Nephrology
Zaloska 7
1000 Ljubljana
Country 42935 0
Slovenia
Phone 42935 0
+386 1 522 3112
Fax 42935 0
Email 42935 0
[email protected]
Contact person for scientific queries
Name 42936 0
Dr Jakob Gubensek
Address 42936 0
University Medical Center Ljubljana
Dept. of Nephrology
Zaloska 7
1000 Ljubljana
Country 42936 0
Slovenia
Phone 42936 0
+386 1 522 3112
Fax 42936 0
Email 42936 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
EmbaseCalcium mass balance during citrate hemodialysis: A randomized controlled trial comparing normal and low ionized calcium target ranges.2016https://dx.doi.org/10.1371/journal.pone.0168593
N.B. These documents automatically identified may not have been verified by the study sponsor.