Trials / Unknown
UnknownNCT02848937
Calcium Mass Balance and Dialytic Efficiency of a New cITRate-containing and Acetate-free Dialysis flUidS: CITRUS Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 62 (estimated)
- Sponsor
- Azienda Ospedaliera, Ospedale Civile di Legnano · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bath 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 |
| DEVICE | Bath with citrate and Ca_eq | bath with citrate and Ca\_eq of concentrate with 3 mM acetate and 1.5 mM of calcium |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2016-07-01
- Completion
- 2016-12-01
- First posted
- 2016-07-29
- Last updated
- 2016-07-29
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02848937. Inclusion in this directory is not an endorsement.