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

July 26, 2016 updated by: Carlo Maria Guastoni, Azienda Ospedaliera, Ospedale Civile di Legnano
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Select Bag Citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera, Ospedale Civile di Legnano

Collaborators

AO Garbagnate-Bollate

Investigators

  • Principal Investigator: Carlo Maria Guastoni, DR, Asst Ovest Mi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 29, 2016

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-050313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ESRD

Clinical Trials on Bath with citrate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe