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| Name | Class |
|---|---|
| AO Garbagnate-Bollate | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bath with citrate | Each patient will participate in two phases of the study. The first phase has the aim to identify the concentration of calcium in the 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 (4 weeks). Each week, the concentration of calcium in the bath with citrate is increased from 1.5-, to 1.65, to 1.75 mM. •Concentrate SelectBag One (with 3 mM acetic acid) and SelectBag Citrate (with 1 mM of citric acid). The potassium in the bath will be chosen on the basis of the needs of the patient (2 to 3.5 mM) and will be maintained in all concentrates.•All treatment parameters (Qb, time of treatment, weight loss and anticoagulant dose) should be overlapped at all stages of the study |
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| Bath with citrate and Ca_eq | Each patient will participate in two phases of the study. In the second phase will evaluate the effectiveness of the purification concentrate with 1 mM citrate and Ca_eq compared to the concentrate with 3 mM acetate and 1.5 mM calcium. For each of the sessions will be used the following materials:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bath with citrate | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Evaluation of variations of the parameters of mineral metabolism |
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Inclusion Criteria:
Patients clinically stable.
Exclusion Criteria:
Patients with the features listed below may not be enrolled in this survey:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo Maria Guastoni, DR | Contact | +39 3482807180 | carlo.guastoni@asst-ovestmi.it | |
| Ugo Teatini, DR | Contact | +39 347 8851870 | UTeatini@aogarbagnate.lombardia.it |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Maria Guastoni, DR | Asst Ovest Mi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carlo Maria Guastoni | Recruiting | Legnano | Milano | 20025 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10692276 | Background | Ahmad S, Callan R, Cole JJ, Blagg CR. Dialysate made from dry chemicals using citric acid increases dialysis dose. Am J Kidney Dis. 2000 Mar;35(3):493-9. doi: 10.1016/s0272-6386(00)70203-4. | |
| 16253731 | Background | Bauer E, Derfler K, Joukhadar C, Druml W. Citrate kinetics in patients receiving long-term hemodialysis therapy. Am J Kidney Dis. 2005 Nov;46(5):903-7. doi: 10.1053/j.ajkd.2005.07.041. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D001494 | Baths |
| ID | Term |
|---|---|
| D001452 | Balneology |
| D013812 | Therapeutics |
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| Bath with citrate and Ca_eq | Device | bath with citrate and Ca_eq of concentrate with 3 mM acetate and 1.5 mM of calcium |
|
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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 |
| 6 months |
| 19661218 | Background | Kossmann RJ, Gonzales A, Callan R, Ahmad S. Increased efficiency of hemodialysis with citrate dialysate: a prospective controlled study. Clin J Am Soc Nephrol. 2009 Sep;4(9):1459-64. doi: 10.2215/CJN.02590409. Epub 2009 Aug 6. |
| 22357700 | Background | Bosticardo G, Malberti F, Basile C, Leardini L, Libutti P, Filiberti O, Schillaci E, Ravani P. Optimizing the dialysate calcium concentration in bicarbonate haemodialysis. Nephrol Dial Transplant. 2012 Jun;27(6):2489-96. doi: 10.1093/ndt/gfr733. Epub 2012 Feb 21. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |