Clinical trial NCT02848937: Calcium Mass Balance and Dialytic Efficiency of a New cITRate-containing and Acetate-free Dialysis flUidS: CITRUS Study
Official title: Calcium Mass Balance and Dialytic Efficiency of a New cITRate-containing and Acetate-free Dialysis flUidS: CITRUS Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ESRD
Keywords: calcium balance
dialysis
concentrate with citrate
Lead sponsor: Azienda Ospedaliera, Ospedale Civile di Legnano
Sponsor class: OTHER
Collaborators: name: AO Garbagnate-Bollate
First posted: 2016-07-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients clinically stable.
* 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.

Brief summary: This study aimed to evaluate the effect on the calcium balance of a concentrate with 1 mM citrate and locate the equivalent concentration of calcium (Ca_eq) at a concentration of 3 mM acetate and traditional with 1.5 mM calcium in HD. The secondary objective is to evaluate the performance in the medium term of purifying the concentrate with 1 mM citrate and Ca_eq, compared to traditional concentrated with 3 mM acetate and 1.5 mM calcium in HD.

Detailed description: Primary Objective The primary objective of this study is to find the formulation of calcium (1.50, 1.65 and 1.75 mM) in the bath with 1 mM citrate which allows the equivalence of calcium balance (Ca_eq) in a sitting HD compared to traditional concentrated with 3 mM of calcium acetate and 1.5.

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).

Eligibility criteria: Inclusion Criteria:

* Patients clinically stable.

  * 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:

* Patients with the features listed below may not be enrolled in this survey:

  * Life expectancy \<6 months.
  * residual diuresis\> 500 ml / day.

Primary outcomes:
measure: Plasma calcium level evaluation (mEq/l)
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate purifying performance of small and medium-sized molecules in HD (Kt/V)
timeFrame: 6 months
measure: Evaluation of variations of the parameters of mineral metabolism
timeFrame: 6 months
Other outcomes:
Locations:
city: Legnano
country: Italy
facility: Carlo Maria Guastoni
state: Milano
Study officials:
affiliation: Asst Ovest Mi
name: Carlo Maria Guastoni, DR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.