ESRD
Conditions
Keywords
calcium balance, dialysis, concentrate with citrate
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).
Interventions
DEVICEBath 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
DEVICEBath with citrate and Ca_eq
bath with citrate and Ca\_eq of concentrate with 3 mM acetate and 1.5 mM of calcium
Sponsors
AO Garbagnate-Bollate
Azienda Ospedaliera, Ospedale Civile di Legnano
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma calcium level evaluation (mEq/l) | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate purifying performance of small and medium-sized molecules in HD (Kt/V) | 6 months | 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 |
| Evaluation of variations of the parameters of mineral metabolism | 6 months | 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 |
Countries
Italy
Contacts
Primary ContactCarlo Maria Guastoni, DR
Backup ContactUgo Teatini, DR
Outcome results
None listed