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The calcification propensity of uremic patients on hemodialysis.


- candidate number22011
- NTR NumberNTR5226
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-apr-2015
- Secondary IDsNL 53094.068.15 ARB 53094
- Public TitleThe calcification propensity of uremic patients on hemodialysis.
- Scientific TitleEffect of calcium and citrate dialysate concentrations on the calcification propensity in hemodialysis; a prospective randomized controlled cross-over trial.
- ACRONYM
- hypothesisThe use of lower concentrations of calcium dialysate and the use of calcium citrate dialysate improves calcicifaction propensity of serum of hemodialysis patients.
- Healt Condition(s) or Problem(s) studiedCalcification propensity, Vasculair calcification, Dialysis patients
- Inclusion criteriaPrevalent HD patients with a dialysis vintage of at least 3 months.
Hemodynamically stable on dialysis.
AV-fistula enabling double-needle vascular access with a blood flow rate of at least 300 ml/min. Age above 18 years of age. Informed consent.
- Exclusion criteriaWithdrawal of consent
Acute intercurrent illness (infection, malignancy, cardiovascular event, uncontrolled diabetes)
Long QT syndrome
Frequent intra-dialytic hypotension (>10% of treatments)
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate1-okt-2016
- Target number of participants22
- InterventionsChange in dialysate calcium concentration and using calcium-citrate dialysate.
- Primary outcomeCalcification propensity of the serum measured by the transformation time from primary to secondary calciprotein particles (T50).
- Secondary outcomeIncreased vascular velocity measured by a pulse wave velocity meter.
- TimepointsChange in dialysate composition will be during 1 week on dialysis.
- Trial web site-
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIES Marijke Dekker
- CONTACT for SCIENTIFIC QUERIES Marijke Dekker
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Fresenius Medical Care
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD23-apr-2015 - 30-jul-2015


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