ESRD Clinical Trial
Official title:
Calcium Mass Balance and Dialytic Efficiency of a New cITRate-containing and Acetate-free Dialysis flUidS: CITRUS Study
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.
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).
;
Observational Model: Case-Crossover, Time Perspective: Prospective
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