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Trial registered on ANZCTR


Registration number
ACTRN12613001117707
Ethics application status
Approved
Date submitted
24/09/2013
Date registered
4/10/2013
Date last updated
4/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predilution online hemodiafiltration with Citrasate - is it a possible option for heparin free procedure?
Scientific title
Citrate acid concentrate Citrasate for online predilution hemodiafiltration in patients on maintenance hemodialysis as an alternative of anticoagulation free procedure - comparison with acetate-based concentrate.
Secondary ID [1] 282524 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anticoagulation during renal replacement therapy 289186 0
Condition category
Condition code
Renal and Urogenital 289509 289509 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a random order patients undergo one 4 hr procedure of online predilution hemodiafiltration with acetic acid or citrate acid (Citrasate) concentrate respectively. In two weeks and in a cross-over manner they undergo the second study procedure with citrate or acetic acid respectively. Citrate concentration in Citrasate is 0,8 mmol/l.
Intervention code [1] 287183 0
Treatment: Other
Comparator / control treatment
Acetic acid based concentrate will be used as a control treatment. Acetate concentration in dialysate is 3,0 mmol/l.
Control group
Active

Outcomes
Primary outcome [1] 289658 0
Successful finishing of HDF procedure without significant problems with blood clotting that would cause the extracorporeal circuit system exchange.
Timepoint [1] 289658 0
240 min of HDF procedure
Secondary outcome [1] 302964 0
single pool Kt/V - HDF procedure adequacy calculated by Daugirdas formula: -ln((BUNPost / BUNPre) - (0.008 * Hours)) + ((4 - (3.5 * BUNPost / BUNPre)) * UFVol / WeightPost).
BUN = blood urea nitrogen, post = after dialysis, pre = before dialysis, hours = hours of dialysis, UFvol = volume ultrafiltrated, weightPost = weight after dialysis.
Timepoint [1] 302964 0
240 min of HDF procedure
Secondary outcome [2] 303915 0
plasma thrombin-antithrombin (TAT) concentration during HDF procedure by Enzygnost TAT micro, an ELISA assay for thrombin-antithrombin complex determination
Timepoint [2] 303915 0
minute 0, 60, 120 and 240
Secondary outcome [3] 303916 0
transmembrane pressure (TMP) during HDF procedure - online data from dialysis monitor will be recorded
Timepoint [3] 303916 0
minute 0, 60, 120 and 240
Secondary outcome [4] 304987 0
Blood clotting scale of dialyser after finishing HDF:
1 = no visible clots, 2 = clots in less than 30% of fibres, 3 = clots in 30-60% of fibres, 4 = clots in 60-90% of fibres, blood from the extracorporeal circuit is possible to return to patient´s circulation, 5 = clotted dialyser, it is not possible to return blood back to patient´s circulation. The evaluation of dialyser will be performed by the independent dialysis stuff.
Timepoint [4] 304987 0
240 min

Eligibility
Key inclusion criteria
1. chronic kidney disease 5/5 K/DOQI, more than 3 months on maintenance dialysis treatment,
2. native arteriovenous fistula with blood flow at least 300 ml/min.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. laboratory markers of hepatopathy ( = ALT and AST more than double of upper borderline lab value),
2. hemostasis disorder ( = pathological value of prothrombin time and aPTT and thrombocyte count less than 100 000/ul),
3. antithrombotic treatment excluding acetylsalicylic acid (aspirin)
4. malignancy

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)
After informed consent signature, patients will be randomized (simple randomization) to start the study with Citrasate dialysate or acetate dialysate resp.
Sequentially numbered sealed envelopes will be used for allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/09/2013
Actual
13/09/2013
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] 5103 0
Czech Republic
State/province [1] 5103 0

Funding & Sponsors
Funding source category [1] 287344 0
Government body
Name [1] 287344 0
Project ED2.1.00/03.0076 from European Regional Development Fund.
Country [1] 287344 0
Czech Republic
Funding source category [2] 287345 0
University
Name [2] 287345 0
Charles University Research Fund (project number P36)
Country [2] 287345 0
Czech Republic
Primary sponsor type
Individual
Name
Pavlina Richtrova, M.D., Ph.D.
Address
Division of Nephrology, Department of Internal Medicine I Charles University Medical School and Teaching Hospital, alej Svobody 80, 30460 Plzen Czech Republic
Country
Czech Republic
Secondary sponsor category [1] 286093 0
None
Name [1] 286093 0
Address [1] 286093 0
Country [1] 286093 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
We want to test the hypothesis, 4 hr online predilution HDF with Citrasate is possible to be realized without manifest clotting problems even with no anticoagulation therapy.
As a secondary outcome we want to describe coagulation cascade activation based on TAT concentration during this HDF procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40150 0
Dr Pavlina Richtrova, MD, PhD
Address 40150 0
Department of Internal Medicine I, Charles University Medical School and Teaching Hospital, alej Svobody 80, 30460 Plzen, Czech Republic
Country 40150 0
Czech Republic
Phone 40150 0
+420377103285
Fax 40150 0
Email 40150 0
[email protected]
Contact person for public queries
Name 40151 0
Pavlina Richtrova, MD, PhD
Address 40151 0
Department of Internal Medicine I, Charles University Medical School and Teaching Hospital, alej Svobody 80, 30460 Plzen, Czech Republic
Country 40151 0
Czech Republic
Phone 40151 0
+420377103285
Fax 40151 0
Email 40151 0
[email protected]
Contact person for scientific queries
Name 40152 0
Pavlina Richtrova, MD, PhD
Address 40152 0
Department of Internal Medicine I, Charles University Medical School and Teaching Hospital, alej Svobody 80, 30460 Plzen, Czech Republic
Country 40152 0
Czech Republic
Phone 40152 0
+420377103285
Fax 40152 0
Email 40152 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
EmbaseCitrate-Buffered Dialysis Solution (Citrasate) Allows Avoidance of Anticoagulation During Intermittent Hemodiafiltration-At the Cost of Decreased Performance and Systemic Biocompatibility.2017https://dx.doi.org/10.1111/aor.12851
N.B. These documents automatically identified may not have been verified by the study sponsor.