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).
Study Type
OBSERVATIONAL
Enrollment
62
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 of concentrate with 3 mM acetate and 1.5 mM of calcium
Carlo Maria Guastoni
Legnano, Milano, Italy
RECRUITINGPlasma calcium level evaluation (mEq/l)
Calcium balance from data of the calcium ion and total dialysate compartment. Complete blood count pre-and post-dialysis, total Proteins pre-and post-dialysis, will be collected from the patient's blood sitting in the middle of the week. Biochemical data from the dialysis fluid and spent dialysate sitting in the middle of the week:Calcium ion (EGA) and total in the dialysis fluid in the following times: 5, 120, end of dialysis; Calcium ion (EGA) and total effluent in the following times: 5, 120, end of dialysis
Time frame: 6 months
Evaluate purifying performance of small and medium-sized molecules in HD (Kt/V)
Evaluate the purifying performance of small and medium-sized molecules in HD (EKt/V) with concentrated with 1 mM citrate and Ca\_eq compared to traditional concentrated with 3 mM calcium acetate and 1.5
Time frame: 6 months
Evaluation of variations of the parameters of mineral metabolism
Evaluate the variations of the parameters of mineral metabolism: Predialytic values of PTH (mEq/l), alkaline phosphatase treatments (U/I) with concentrated Cit (1 mM citrate and Ca\_eq) and concentrated with traditional Ac (3 mM calcium acetate and 1.5
Time frame: 6 months
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