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

• Conditions: ESRD
• Interventions: Device: Bath with citrate and Ca_eq; Device: Bath with citrate

• Registration Number: NCT02848937
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-03
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-29
• Last Update Posted: 2016-07-29
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bath with citrate and Ca_eq	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.
Bath with citrate	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Carlo Maria Guastoni; 🇮🇹 Legnano, Milano, Italy