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

ESRD Clinical Trial

— CITRUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02848937
• Other study ID #: CT-050313
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2016
• Last updated: July 26, 2016
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Azienda Ospedaliera, Ospedale Civile di Legnano
• Contact: Carlo Maria Guastoni, DR
• Phone: +39 3482807180
• Email: carlo.guastoni[@]asst-ovestmi.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• ESRD

Intervention

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
• Bath with citrate and Ca_eq
bath with citrate and Ca_eq of concentrate with 3 mM acetate and 1.5 mM of calcium

Locations

Country	Name	City	State
Italy	Carlo Maria Guastoni	Legnano	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera, Ospedale Civile di Legnano	AO Garbagnate-Bollate

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Evaluation of variations of the parameters of mineral metabolism	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	No