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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?
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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.
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Secondary ID [1]
282524
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Nil
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Universal Trial Number (UTN)
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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:
anticoagulation during renal replacement therapy
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Condition category
Condition code
Renal and Urogenital
289509
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0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
287183
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Treatment: Other
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Comparator / control treatment
Acetic acid based concentrate will be used as a control treatment. Acetate concentration in dialysate is 3,0 mmol/l.
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Control group
Active
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Outcomes
Primary outcome [1]
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Successful finishing of HDF procedure without significant problems with blood clotting that would cause the extracorporeal circuit system exchange.
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Assessment method [1]
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Timepoint [1]
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240 min of HDF procedure
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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240 min of HDF procedure
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Secondary outcome [2]
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plasma thrombin-antithrombin (TAT) concentration during HDF procedure by Enzygnost TAT micro, an ELISA assay for thrombin-antithrombin complex determination
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Assessment method [2]
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Timepoint [2]
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minute 0, 60, 120 and 240
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Secondary outcome [3]
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transmembrane pressure (TMP) during HDF procedure - online data from dialysis monitor will be recorded
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Assessment method [3]
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Timepoint [3]
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minute 0, 60, 120 and 240
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Secondary outcome [4]
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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.
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Assessment method [4]
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Timepoint [4]
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240 min
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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.
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Minimum age
18
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
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
13/09/2013
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Actual
13/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Czech Republic
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Project ED2.1.00/03.0076 from European Regional Development Fund.
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Address [1]
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Ministry of Education, Youth, and Physical Training of the Czech Republic, Karmelitska 7, 118 12 Prague, Czech Republic
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Country [1]
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Czech Republic
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Funding source category [2]
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University
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Name [2]
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Charles University Research Fund (project number P36)
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Address [2]
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Charles University in Prague, Rectorate, Ovocny trh 5, 116 36 Prague
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Country [2]
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Czech Republic
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Primary sponsor type
Individual
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Name
Pavlina Richtrova, M.D., Ph.D.
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Address
Division of Nephrology, Department of Internal Medicine I Charles University Medical School and Teaching Hospital, alej Svobody 80, 30460 Plzen Czech Republic
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Country
Czech Republic
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
286093
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Ethics approval
Ethics application status
Approved
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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.
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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
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Dr Pavlina Richtrova, MD, PhD
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Address
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Department of Internal Medicine I, Charles University Medical School and Teaching Hospital, alej Svobody 80, 30460 Plzen, Czech Republic
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Country
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Czech Republic
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Phone
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+420377103285
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Pavlina Richtrova, MD, PhD
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Address
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Department of Internal Medicine I, Charles University Medical School and Teaching Hospital, alej Svobody 80, 30460 Plzen, Czech Republic
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Country
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Czech Republic
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Phone
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+420377103285
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Pavlina Richtrova, MD, PhD
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Address
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Department of Internal Medicine I, Charles University Medical School and Teaching Hospital, alej Svobody 80, 30460 Plzen, Czech Republic
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Country
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Czech Republic
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Phone
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+420377103285
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Fax
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Email
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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
Source
Title
Year of Publication
DOI
Embase
Citrate-Buffered Dialysis Solution (Citrasate) Allows Avoidance of Anticoagulation During Intermittent Hemodiafiltration-At the Cost of Decreased Performance and Systemic Biocompatibility.
2017
https://dx.doi.org/10.1111/aor.12851
N.B. These documents automatically identified may not have been verified by the study sponsor.
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