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Trial registered on ANZCTR
Registration number
ACTRN12613000405718
Ethics application status
Approved
Date submitted
10/04/2013
Date registered
12/04/2013
Date last updated
2/12/2015
Type of registration
Retrospectively registered
Titles & IDs
Public title
Study of hemodialysis patients where Calcium Flux into the dialysate is measured during anticoagulation with sodium citrate
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Scientific title
Assessment of calcium flux during regional Citrate Haemodialysis
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Secondary ID [1]
282292
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ETHLR.11.236
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Universal Trial Number (UTN)
U1111-1141-7543
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hemodialysis
288834
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Anticoagulation
288835
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Condition category
Condition code
Renal and Urogenital
289190
289190
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0
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Kidney disease
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The calcium in a total spent dialysate is measured by collection into a 200L vessel. The total calcium content in the spent dialysate is subtracted from the calcium infused during during citrate anticoagulation to provide the net amount of calcium retained by the patient (the calcium flux). The dialysate is collected for the duration of the dialysis session (usually 4 hours)
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Intervention code [1]
286919
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
289298
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The mass of calcium infused during citrate antocoagulated dialysis is measured by multiplying the volume infused by the concentration in the infused liquid. The mass of calcium in the spent dialysate is determined by collecting spent dialysate over the entire duration of the patient's dialysis session (usually 4 hours). The difference between these two figures produces the net calcium flux into or out of the patient during the dialysis therapy
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Assessment method [1]
289298
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Timepoint [1]
289298
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One dialysis session (usually 4 hours)
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Secondary outcome [1]
302184
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The mass of citrate infused during citrate antocoagulated dialysis is measured by multiplying the volume infused by the concentration in the infused fluid. The mass of citrae in the spent dialysate is determined by collecting spent dialysate over the entire duration of the patient's dialysis session (usually 4 hours). The difference between these two figures produces the net citrate returned to the patient during therapy. If expressed as a proportion of the mass infused, it yields the proportional extration during dialysis.
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Assessment method [1]
302184
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Timepoint [1]
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4-5hours
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Eligibility
Key inclusion criteria
Prescribed regional citrate hemodialysis by renal physician
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
None
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Descriptive statistics.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/09/2011
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Date of last participant enrolment
Anticipated
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Actual
1/10/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
ACT
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Recruitment hospital [1]
860
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The Canberra Hospital - Garran
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Recruitment postcode(s) [1]
6674
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2605 - Garran
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Funding & Sponsors
Funding source category [1]
287067
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Self funded/Unfunded
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Name [1]
287067
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Address [1]
287067
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Country [1]
287067
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Primary sponsor type
Hospital
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Name
The Canberra Hospital
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Address
77 Yamba Drive, Garran, ACT 2605
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Country
Australia
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Secondary sponsor category [1]
285842
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None
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Name [1]
285842
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Address [1]
285842
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Country [1]
285842
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
293956
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The ACT Health Human Research Ethics Committee
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Ethics committee address [1]
293956
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Building 10, Level 6, The Canberra Hospital, 77 Yamba Drive, Garran, ACT 2605
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Ethics committee country [1]
293956
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Australia
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Date submitted for ethics approval [1]
293956
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06/10/2011
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Approval date [1]
293956
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19/10/2011
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Ethics approval number [1]
293956
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ETHLR.11.236
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Summary
Brief summary
A convenience sample of patients receiving regional citrate hemodialyis by means of the Canberra Hospital Protocol are assessed for calcium and citrate flux during dialysis by means of a complete dialysate collection.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
39166
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Dr Richard Francis Singer
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Address
39166
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Renal Unit
The Canberra Hospital
77 Yamba Drive
Garran
ACT 2605
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Country
39166
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Australia
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Phone
39166
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+61262442222
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Fax
39166
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Email
39166
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[email protected]
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Contact person for public queries
Name
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Dr Girish Talaulikar
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Address
39167
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Renal Unit
The Canberra Hospital
77 Yamba Drive
Garran
ACT 2605
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Country
39167
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Australia
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Phone
39167
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+61262442222
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Fax
39167
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Email
39167
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[email protected]
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Contact person for scientific queries
Name
39168
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Mr Oliver Williams
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Address
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Medical Student
Renal Unit
The Canberra Hospital
77 Yamba Drive
Garran
ACT 2605
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Country
39168
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Australia
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Phone
39168
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+61262442222
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Fax
39168
0
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Email
39168
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[email protected]
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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
No additional documents have been identified.
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