Calcium Mass Balance and Dialytic Efficiency of a New cITRate-containing and Acetate-free Dialysis flUidS: CITRUS Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ESRD
- Sponsor
- Azienda Ospedaliera, Ospedale Civile di Legnano
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Plasma calcium level evaluation (mEq/l)
- Last Updated
- 9 years ago
Overview
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).
Investigators
Carlo Maria Guastoni
DPT Director
Azienda Ospedaliera, Ospedale Civile di Legnano
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.
Outcomes
Primary Outcomes
Plasma calcium level evaluation (mEq/l)
Time Frame: 6 months
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
Secondary Outcomes
- Evaluate purifying performance of small and medium-sized molecules in HD (Kt/V)(6 months)
- Evaluation of variations of the parameters of mineral metabolism(6 months)