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Trial registered on ANZCTR


Registration number
ACTRN12612001143819
Ethics application status
Approved
Date submitted
23/10/2012
Date registered
29/10/2012
Date last updated
29/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hemodialyzer biocompatibility with citrate-based vs. acetate-based dialysate
Scientific title
Local dialyzer biocompatibility parameters (membrane biofilm composition) in patients on maintenance hemodialysis - comparison of acetate-based and citrate-based dialysate.
Secondary ID [1] 281423 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemodialyzer biocompatibility in patients treated with regular hemodialysis 287674 0
kidney disease 287708 0
Condition category
Condition code
Renal and Urogenital 288015 288015 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be switched to citrate-based dialysate (intervention) in a cross-over fashion. The dialysate will be applied six times (thrice weekly for two weeks), patients are exposed to the dialysate for 4 hours each time. Neither base (citrate or acetate) is administered directly to the patient (dialysate is separated from the bloodstream by dialysis membrane), which makes it impossible to define the dose. That's also why it should not be considered drug intervention. Citrate concentration in dialysate is 2.4 mmol/l.
Intervention code [1] 285923 0
Treatment: Other
Comparator / control treatment
Acetate-based dialysate will be used as control treatment. The dialysate will be applied six times (thrice weekly for two weeks), patients are exposed to the dialysate for 4 hours each time. Acetate concentration in dialysate is 3.0 mmol/l.
Control group
Active

Outcomes
Primary outcome [1] 288228 0
eluate total protein (mg): after dialysis, protein biofilm will be eluted from the dialyzer by acetic flush, total protein will be measured by Bradford dye binding assay
Timepoint [1] 288228 0
week 2 (acetate-based dialysate), week 4 (citrate-based dialysate)
Primary outcome [2] 288229 0
eluate fibrinogen A chain fragments (%) will be assessed as protein spot density in 2-dimensional electrophoretic gels
Timepoint [2] 288229 0
week 2 (acetate-based dialysate), week 4 (citrate-based dialysate)
Primary outcome [3] 288230 0
eluate haemoglobin A and B (%) will be assessed as protein spot density in 2-dimensional electrophoretic gels
Timepoint [3] 288230 0
week 2 (acetate-based dialysate), week 4 (citrate-based dialysate)
Secondary outcome [1] 299661 0
eluate factor H-related protein 3 (FHR3 %) will be assessed as protein spot density in 2-dimensional electrophoretic gels
Timepoint [1] 299661 0
week 2 (acetate-based dialysate), week 4 (citrate-based dialysate)

Eligibility
Key inclusion criteria
regular dialysis > 3 months
native arteriovenous fistula & blood flow > 250ml/min
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of thrombosis (other than av fistula) or anticoagulation (other than for hemodialysis)
bleeding disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All subjects are primarily treated with acetate-based dialysate and all will be switched to citrate-based dialysate
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
1 week screening period followed by 2 weeks of acetate dialysate and another 2 weeks of citrate dialysate - each 2 week period includes 1 week wash-out and 1 week evaluation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 4618 0
Czech Republic
State/province [1] 4618 0

Funding & Sponsors
Funding source category [1] 286192 0
University
Name [1] 286192 0
Charles University in Prague
Country [1] 286192 0
Czech Republic
Primary sponsor type
University
Name
Charles University in Prague
Address
Husova 3
30605
Plzen
Country
Czech Republic
Secondary sponsor category [1] 285002 0
None
Name [1] 285002 0
Address [1] 285002 0
Country [1] 285002 0
Other collaborator category [1] 277136 0
Hospital
Name [1] 277136 0
Teaching Hospital in Plzen
Address [1] 277136 0
Alej Svobody 80
30460
Plzen
Country [1] 277136 0
Czech Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288267 0
Teaching Hospital in Plzen Local Ethics Comittee
Ethics committee address [1] 288267 0
E. Benese 13
30599
Plzen
Ethics committee country [1] 288267 0
Czech Republic
Date submitted for ethics approval [1] 288267 0
12/10/2012
Approval date [1] 288267 0
Ethics approval number [1] 288267 0

Summary
Brief summary
Hemodialyzer biocompatibility in terms of biofilm (secondary membrane) quantity and quality (protein composition) may depend on dialysate formula. Specifically, citrate instead of acetate might reduce the amount of protein adsorbed to dialysis membrane, stable fibrin formation as well as complement binding, and explain higher filter permeability (clearance) previously observed with citrate-based dialysate. Acetic elution of dialyzer will be performed at the end of dialysis session in a cross-over fashion (first with acetate, then with citrate), eluate protein content ascertained and factors of coagulation and complement evaluated
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34859 0
Address 34859 0
Country 34859 0
Phone 34859 0
Fax 34859 0
Email 34859 0
Contact person for public queries
Name 18106 0
Jan Mares
Address 18106 0
Proteomic Laboratory, Charles University in Plzen
Alej Svobody 80
30460 Plzen
Country 18106 0
Czech Republic
Phone 18106 0
+420 377 103 573
Fax 18106 0
Email 18106 0
[email protected]
Contact person for scientific queries
Name 9034 0
Jan Mares
Address 9034 0
Proteomic Laboratory, Charles University in Plzen
Alej Svobody 80
30460 Plzen
Country 9034 0
Czech Republic
Phone 9034 0
+420 377 103 573
Fax 9034 0
Email 9034 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
No additional documents have been identified.