Benefits of Hemodialysis With Citrate (ABC-treat) Study (ABC-treat)

October 19, 2017 updated by: Fundación Senefro

Prospective Randomized Multicenter Study to Demonstrate the Benefits of Hemodialysis Without Acetate (With Citrate): ABC-treat Study

Prospective randomized cross-over multicenter study to demonstrate the benefits of hemodialysis without acetate dialysate, with citrate.

32 weeks duration, in two phases. In the first, half of the patients started with citrate dialysate for 16 weeks and the other half with acetate dialysate, and then patients cross.

The primary objective is to analyze the effect of citrate dialysate on acid base balance decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary objective: to analyze the effect of citrate dialysate on acid base balance decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis.

Secondary objectives:

  • Evaluate the effect of dialysate on the variation of calcium pre and post-dialytic, as well as on the parathormone (PTH)
  • Assess the effect of dialysate on inflammation
  • Assess the effect of dialysate on the Elimination of small and medium-sized molecules
  • Assess the effect of dialysate on the tolerance to the hemodialysis sessions
  • Assess the effect of dialysate on nutritional parameters

Patients: Adult patients dialysed three times per week for at least 3 months will be enrolled in 12 Spanish dialysis centres. Catheter as vascular access will be excluded.

Design: prospective randomized multicenter, cross-over trial of chronic haemodialysis patients to compare the effect of citrate dialysate with acetate dialysate.

Duration of study: 32 weeks, in two phases. Randomised to 16 weeks of hemodialysis with acetate followed by 16 weeks of citrate or 16 weeks of hemodialysis with citrate followed by 16 weeks of acetate. Each patient will serve as control of itself and there will be no changes in the pattern of dialysis during the study with the exception of the dialysate, following the usual pattern of work

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Spain
      • Guadalajara, Spain, 19002
        • Recruiting
        • Hospital Universitario de Guadalajara
        • Contact:
        • Sub-Investigator:
          • Marta Sánchez
        • Sub-Investigator:
          • Maria Angeles Basterrechea
        • Sub-Investigator:
          • Luis Alberto Blazquez
        • Sub-Investigator:
          • Ruth Alexandra Fiallos
        • Sub-Investigator:
          • Paola Milena Villabon
        • Principal Investigator:
          • Gabriel De Arriba
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
        • Sub-Investigator:
          • Claudia Yuste
        • Principal Investigator:
          • Eva Mérida
      • Madrid, Spain, 28030
        • Recruiting
        • Universitary Hospital Infanta Leonor
        • Contact:
        • Principal Investigator:
          • Patricia de Sequera, PhD
        • Sub-Investigator:
          • Rafael Pérez
      • Ourense, Spain, 32205
        • Recruiting
        • Complexo Hospitalario Universitario de Ourense
        • Contact:
        • Sub-Investigator:
          • Beatriz Ferreiro
        • Sub-Investigator:
          • Elena Iglesias
        • Sub-Investigator:
          • Maria Jesús Camba
        • Sub-Investigator:
          • María Paz Borrajo
        • Principal Investigator:
          • Alfoso Otero
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
        • Sub-Investigator:
          • Amelia Dueñas
        • Sub-Investigator:
          • María Aguilar
        • Principal Investigator:
          • Luis Gil
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen De La Macarena
        • Contact:
        • Sub-Investigator:
          • Clotilde Ríos
        • Sub-Investigator:
          • Rocío Molas
        • Principal Investigator:
          • Rocío Valverde
    • Castellón
      • Castelló de la Plana, Castellón, Spain, 12004
        • Recruiting
        • Hospital General de Castellón
        • Contact:
        • Sub-Investigator:
          • Alba Segarra
        • Sub-Investigator:
          • Alejandro Pérez-Alba
        • Principal Investigator:
          • Ramón Pons
    • Madrid
      • Coslada, Madrid, Spain, 28822
        • Recruiting
        • Hospital del Henares
        • Contact:
        • Sub-Investigator:
          • Jose Luis Merino
        • Sub-Investigator:
          • Patricia Domínguez
        • Sub-Investigator:
          • Vicente Paraiso
        • Principal Investigator:
          • Blanca Bueno
      • San Sebastian de los Reyes, Madrid, Spain, 28702
        • Recruiting
        • Hospital Universitario Infanta Sofía
        • Contact:
        • Sub-Investigator:
          • Yesica Amezquita
        • Sub-Investigator:
          • Antonio Cirugeda
        • Sub-Investigator:
          • Vicente Barrio
        • Principal Investigator:
          • Rocío Echarri
    • Murcia
      • Cartagena, Murcia, Spain, 30202
        • Recruiting
        • Hospital Universitario Santa Lucía
        • Contact:
        • Sub-Investigator:
          • Manuel Molina
        • Principal Investigator:
          • Gracia Álvarez
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Recruiting
        • Hospital de Basurto
        • Contact:
        • Sub-Investigator:
          • Javier Arrieta
        • Principal Investigator:
          • Iñigo Moina
      • Usansolo, Vizcaya, Spain, 48960

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 to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatient conventional hemodialysis three times per week for at least three months.
  • Arteriovenous fistula as vascular access
  • Patients who have given their informed consent in writing.

Exclusion Criteria:

  • Catheter as vascular access
  • Allergy or intolerance to citrate
  • Patients with sufficient cognitive impairment that would prevent the compression of information and informed consent.
  • Inflammatory intercurrent diseases (chronic infections, autoimmune diseases or tumors) that can mask the results of the study.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Citrate dialysate
Hemodialysis with citrate dialysate during 16 weeks
Other: Citrate dialysate
Compare the effect of citrate dialysate with acetate dialysate
Other Names:
  • Acetate dialysate
NO_INTERVENTION: Acetate dialysate
Hemodialysis with acetate dialysate during 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of citrate dialysate on acid base status in hemodialysis patients measured by pH, BEecf and Bicarbonate at the end of HD session.
Time Frame: 32 weeks
The anion gap will be calculated as: Anion gap = [Na+] - ([Cl-] + [CO3H-])
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the effect of citrate dialysate with acetate dialysate on calcium level
Time Frame: 32 weeks
Calcium (mg/dl) blood determination
32 weeks
Compare the effect of citrate dialysate with acetate dialysate on phosphate level
Time Frame: 32 weeks
Phosphate (mg/dl) blood determination
32 weeks
Compare the effect of citrate dialysate with acetate dialysate on parathormone level.
Time Frame: 32 weeks
Parathormone (pg/ml) blood determination
32 weeks
Inflammation status by blood determination of IL-6
Time Frame: 32 weeks
IL-6 (UI) blood determination
32 weeks
Inflammation status by blood determination of us-PCR
Time Frame: 32 weeks
us-PCR (UI) blood determination
32 weeks
Inflammation status by blood determination of ERI
Time Frame: 32 weeks

EPO Resistance Index (ERI) is calculated according to the following formula:

ERI = EPO Dose (U/kg/week) / Hb (g/dl).
32 weeks
Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Urea
Time Frame: 32 weeks

Urea reduction rates (RR) will be calculated as: RR (%) = [(Cpre - post)/Cpre] x 100.

Where Cpre and Cpost are the concentrations of pre and post dialysis analyzed substances.
32 weeks
Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Beta2-microglobulin
Time Frame: 32 weeks

β2m reduction rates (RR) will be calculated as: RR (%) = [(Cpre - post)/Cpre] x 100.

Where Cpre and Cpost are the concentrations of pre and post dialysis analyzed substances.

β2m concentrations at the end of the session will be corrected for concentration using a correction factor (FC) based on concentration of plasma proteins (PT): FC = PTpre/PTpost Where PTpre and PTpost are the concentrations of pre and post dialysis total proteins.
32 weeks
Effect of citrate dialysate on the tolerance to the hemodialysis sessions by determining number of intradyalitic hypotensions
Time Frame: 32 weeks
Compare the effect of citrate dialysate with acetate dialysate on reduction ratio (RR) of hypotensive episodes (clinical syntoms) during the hemodialysis sessions
32 weeks
Effect of citrate dialysate on the nutritional parameters measured by biological parameters
Time Frame: 32 weeks
Weight (Kg).
32 weeks
Effect of citrate dialysate on the nutritional parameters measured by biological parameters
Time Frame: 32 weeks
Normalized-protein catabolism rate corrected by body weight (PCR-n) is calculated using the following formula: PCRn = PCR/weight (kg) PCR= (9.35×G) + (0.00028×V) G: generation of interdialytic urea: G = [(C3-C2)×V]/2646 is the generation of interdialytic urea C2 = urea concentration at the end of hemodialysis C3 = urea concentration at the start of the following hemodialysis session parameters
32 weeks

Collaborators and Investigators

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

Sponsor

Fundación Senefro

Collaborators

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Rafael Perez-Garcia, PhD, Nephrology department. Hospital universitario Infanta Leonor

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

Helpful Links

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 (ACTUAL)

May 1, 2016

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

March 31, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (ACTUAL)

October 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABC-Treat

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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