Calcium Mass Balance and Dialytic Efficiency of a New cITRate-containing and Acetate-free Dialysis flUidS: CITRUS Study
NCT ID: NCT02848937
Last Updated: 2016-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
62 participants
OBSERVATIONAL
2013-03-31
2016-12-31
Brief Summary
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Detailed Description
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Secondary objectives
* Evaluate the purifying performance of small and medium-sized molecules in HD with concentrated with 1 mM citrate and Ca\_eq compared to traditional concentrated with 3 mM calcium acetate and 1.5.
* Observe the effects on hemodynamic of the concentrate through the variation of the pre and post-dialysis blood pressure and intradialytic symptoms (cramps, hypotension, headache).
* Evaluate the variations of the parameters of mineral metabolism: Predialytic values of PTH, alkaline phosphatase treatments with concentrated Cit (1 mM citrate and Ca\_eq) and concentrated with traditional Ac (3 mM calcium acetate and 1.5).
Conditions
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Keywords
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Bath with citrate
Each patient will participate in two phases of the study. The first phase has the aim to identify the concentration of calcium in the bath with citrate which allows the equivalence of mass balance (Ca\_eq) compared to the concentrate with 3 mM acetate and 1.5 mM of calcium (4 weeks). Each week, the concentration of calcium in the bath with citrate is increased from 1.5-, to 1.65, to 1.75 mM.
•Concentrate SelectBag One (with 3 mM acetic acid) and SelectBag Citrate (with 1 mM of citric acid). The potassium in the bath will be chosen on the basis of the needs of the patient (2 to 3.5 mM) and will be maintained in all concentrates.•All treatment parameters (Qb, time of treatment, weight loss and anticoagulant dose) should be overlapped at all stages of the study
Bath with citrate
bath with citrate which allows the equivalence of mass balance (Ca\_eq) compared to the concentrate with 3 mM acetate and 1.5 mM of calcium
Bath with citrate and Ca_eq
Each patient will participate in two phases of the study. In the second phase will evaluate the effectiveness of the purification concentrate with 1 mM citrate and Ca\_eq compared to the concentrate with 3 mM acetate and 1.5 mM calcium. For each of the sessions will be used the following materials:
* Filter high permeability (Kuf\> 20ml/mmHg);
* Concentrate SelectBag One (with 3 mM acetic acid) and SelectBag Citrate (with 1 mM of citric acid). The potassium in the bath will be chosen on the basis of the needs of the patient (2 to 3.5 mM) and will be maintained in all concentrates.
* All treatment parameters (Qb, time of treatment, weight loss and anticoagulant dose) should be overlapped at all stages of the study.
Bath with citrate and Ca_eq
bath with citrate and Ca\_eq of concentrate with 3 mM acetate and 1.5 mM of calcium
Interventions
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Bath with citrate
bath with citrate which allows the equivalence of mass balance (Ca\_eq) compared to the concentrate with 3 mM acetate and 1.5 mM of calcium
Bath with citrate and Ca_eq
bath with citrate and Ca\_eq of concentrate with 3 mM acetate and 1.5 mM of calcium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age\> 18 years.
* HD therapy for more than 3 months.
* good vascular access native functionality that enables real blood flow of at least 250 ml / min.
Exclusion Criteria
* Life expectancy \<6 months.
* residual diuresis\> 500 ml / day.
18 Years
ALL
No
Sponsors
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AO Garbagnate-Bollate
UNKNOWN
Azienda Ospedaliera, Ospedale Civile di Legnano
OTHER
Responsible Party
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Carlo Maria Guastoni
DPT Director
Principal Investigators
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Carlo Maria Guastoni, DR
Role: PRINCIPAL_INVESTIGATOR
Asst Ovest Mi
Locations
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Carlo Maria Guastoni
Legnano, Milano, Italy
Countries
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Central Contacts
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Facility Contacts
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Carlo Maria Guastoni, DR
Role: primary
Ugo Teatini, DR
Role: backup
References
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Ahmad S, Callan R, Cole JJ, Blagg CR. Dialysate made from dry chemicals using citric acid increases dialysis dose. Am J Kidney Dis. 2000 Mar;35(3):493-9. doi: 10.1016/s0272-6386(00)70203-4.
Bauer E, Derfler K, Joukhadar C, Druml W. Citrate kinetics in patients receiving long-term hemodialysis therapy. Am J Kidney Dis. 2005 Nov;46(5):903-7. doi: 10.1053/j.ajkd.2005.07.041.
Kossmann RJ, Gonzales A, Callan R, Ahmad S. Increased efficiency of hemodialysis with citrate dialysate: a prospective controlled study. Clin J Am Soc Nephrol. 2009 Sep;4(9):1459-64. doi: 10.2215/CJN.02590409. Epub 2009 Aug 6.
Bosticardo G, Malberti F, Basile C, Leardini L, Libutti P, Filiberti O, Schillaci E, Ravani P. Optimizing the dialysate calcium concentration in bicarbonate haemodialysis. Nephrol Dial Transplant. 2012 Jun;27(6):2489-96. doi: 10.1093/ndt/gfr733. Epub 2012 Feb 21.
Other Identifiers
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CT-050313
Identifier Type: -
Identifier Source: org_study_id