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Calcium Mass Balance and Dialytic Efficiency of a New cITRate-containing and Acetate-free Dialysis flUidS: CITRUS Study (CITRUS)

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ClinicalTrials.gov Identifier: NCT02848937
Recruitment Status : Unknown
Verified July 2016 by Carlo Maria Guastoni, Azienda Ospedaliera, Ospedale Civile di Legnano.
Recruitment status was:  Recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Collaborator:
AO Garbagnate-Bollate
Information provided by (Responsible Party):
Carlo Maria Guastoni, Azienda Ospedaliera, Ospedale Civile di Legnano

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.

Condition or disease Intervention/treatment
ESRD Device: Bath with citrate Device: Bath with citrate and Ca_eq

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).

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Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Calcium Mass Balance and Dialytic Efficiency of a New cITRate-containing and Acetate-free Dialysis flUidS: CITRUS Study
Study Start Date : March 2013
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Dialysis

Group/Cohort Intervention/treatment
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

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
Other Name: Select Bag Citrate

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:

  • Filter high permeability (Kuf> 20ml/mmHg);
  • 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.
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
Other Name: Select Bag Citrate




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluate purifying performance of small and medium-sized molecules in HD (Kt/V) [ Time Frame: 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

  2. Evaluation of variations of the parameters of mineral metabolism [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • 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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848937


Contacts
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Contact: Carlo Maria Guastoni, DR +39 3482807180 carlo.guastoni@asst-ovestmi.it
Contact: Ugo Teatini, DR +39 347 8851870 UTeatini@aogarbagnate.lombardia.it

Locations
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Italy
Carlo Maria Guastoni Recruiting
Legnano, Milano, Italy, 20025
Contact: Carlo Maria Guastoni, DR    + 39 348 2807180    carlo.guastoni@asst-ovestmi.it   
Contact: Ugo Teatini, DR    + 39 347 8851870    UTeatini@aogarbagnate.lombardia.it   
Sub-Investigator: Ugo Teatini, DR         
Sponsors and Collaborators
Azienda Ospedaliera, Ospedale Civile di Legnano
AO Garbagnate-Bollate
Investigators
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Principal Investigator: Carlo Maria Guastoni, DR Asst Ovest Mi

Publications:
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Responsible Party: Carlo Maria Guastoni, DPT Director, Azienda Ospedaliera, Ospedale Civile di Legnano
ClinicalTrials.gov Identifier: NCT02848937     History of Changes
Other Study ID Numbers: CT-050313
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Carlo Maria Guastoni, Azienda Ospedaliera, Ospedale Civile di Legnano:
calcium balance
dialysis
concentrate with citrate
Additional relevant MeSH terms:
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Calcium, Dietary
Citric Acid
Sodium Citrate
Dialysis Solutions
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions