NCT02848937

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

3.3 years

First QC Date

July 20, 2016

Last Update Submit

July 26, 2016

Conditions

ESRD

Keywords

calcium balancedialysisconcentrate with citrate

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Evaluate purifying performance of small and medium-sized molecules in HD (Kt/V)

    6 months

  • Evaluation of variations of the parameters of mineral metabolism

    6 months

Study Arms (2)

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 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

Interventions

Bath with citrateDEVICE

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

Also known as: Select Bag Citrate
Bath with citrate
Bath with citrate and Ca_eqDEVICE

bath with citrate and Ca\_eq of concentrate with 3 mM acetate and 1.5 mM of calcium

Also known as: Select Bag Citrate
Bath with citrate and Ca_eq

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with the features listed below may not be enrolled in this survey:
  • Life expectancy \<6 months.
  • residual diuresis\> 500 ml / day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carlo Maria Guastoni

Legnano, Milano, 20025, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 10692276BACKGROUND

  • 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.

    PMID: 16253731BACKGROUND

  • 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.

    PMID: 19661218BACKGROUND

  • 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.

    PMID: 22357700BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Baths

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BalneologyTherapeutics

Study Officials

  • Carlo Maria Guastoni, DR

    Asst Ovest Mi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Maria Guastoni, DR

CONTACT

+39 3482807180carlo.guastoni@asst-ovestmi.it

Ugo Teatini, DR

CONTACT

+39 347 8851870UTeatini@aogarbagnate.lombardia.it

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DPT Director

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 29, 2016

Study Start

March 1, 2013

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

IT(1)