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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
Scientific title
Assessment of calcium flux during regional Citrate Haemodialysis
Secondary ID [1] 282292 0
ETHLR.11.236
Universal Trial Number (UTN)
U1111-1141-7543
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemodialysis 288834 0
Anticoagulation 288835 0
Condition category
Condition code
Renal and Urogenital 289190 289190 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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)
Intervention code [1] 286919 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289298 0
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
Timepoint [1] 289298 0
One dialysis session (usually 4 hours)
Secondary outcome [1] 302184 0
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.
Timepoint [1] 302184 0
4-5hours

Eligibility
Key inclusion criteria
Prescribed regional citrate hemodialysis by renal physician
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Descriptive statistics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 860 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 6674 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 287067 0
Self funded/Unfunded
Name [1] 287067 0
Address [1] 287067 0
Country [1] 287067 0
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
77 Yamba Drive, Garran, ACT 2605
Country
Australia
Secondary sponsor category [1] 285842 0
None
Name [1] 285842 0
Address [1] 285842 0
Country [1] 285842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293956 0
The ACT Health Human Research Ethics Committee
Ethics committee address [1] 293956 0
Building 10, Level 6, The Canberra Hospital, 77 Yamba Drive, Garran, ACT 2605
Ethics committee country [1] 293956 0
Australia
Date submitted for ethics approval [1] 293956 0
06/10/2011
Approval date [1] 293956 0
19/10/2011
Ethics approval number [1] 293956 0
ETHLR.11.236

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39166 0
Dr Richard Francis Singer
Address 39166 0
Renal Unit
The Canberra Hospital
77 Yamba Drive
Garran
ACT 2605
Country 39166 0
Australia
Phone 39166 0
+61262442222
Fax 39166 0
Email 39166 0
richard.singer@act.gov.au
Contact person for public queries
Name 39167 0
Dr Girish Talaulikar
Address 39167 0
Renal Unit
The Canberra Hospital
77 Yamba Drive
Garran
ACT 2605
Country 39167 0
Australia
Phone 39167 0
+61262442222
Fax 39167 0
Email 39167 0
girish.talaulikar@act.gov.au
Contact person for scientific queries
Name 39168 0
Mr Oliver Williams
Address 39168 0
Medical Student
Renal Unit
The Canberra Hospital
77 Yamba Drive
Garran
ACT 2605
Country 39168 0
Australia
Phone 39168 0
+61262442222
Fax 39168 0
Email 39168 0
u4953206@anu.edu.au

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