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Citrate- Versus Acetate-Based Dialysate in Bicarbonate Haemodialysis: Consequences on Haemodynamics, Coagulation, Acid-Base Status and Electrolytes

NCT00718289 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2008-07-18

No results posted yet for this study

Summary

Background:

A concentrate for bicarbonate haemodialysis acidified with citrate instead of acetate has been marketed in the recent years. The small amount of citrate used (one-fifth of the concentration adopted in regional anticoagulation) protects against intradialyser clotting, minimally affecting the calcium concentration. The aim of this study is to compare the impact of a citrate- and acetate-based dialysate on systemic haemodynamics, coagulation, acid-base status, calcium balance and dialysis efficiency.

Methods:

In 25 patients, 375 dialysis sessions, we will compare acetate (A) with citrate dialysate with (C+) or without (C) calcium supplementation (0.25mmol/L) in a randomized single blind cross-over study. Systemic haemodynamics will be evaluated using pulse wave analysis systems. Coagulation, acid-base status, calcium balance and dialysis efficiency will be assessed using standard biochemical markers.

Conditions

  • Haemodialysis

Interventions

OTHER

Citrate dialysate

dialysis fluid composition for Citrate (C) and Acetate (A): acetate \[3.0 mmol/L in A and 0.3 in C\], citrate \[0 mmol/L in A and 0.8 in C\]

OTHER

Acetate dialysate

dialysis fluid composition for Citrate (C) and Acetate (A): acetate \[3.0 mmol/L in A and 0.3 in C\], citrate \[0 mmol/L in A and 0.8 in C\]

Sponsors & Collaborators

  • Bichsel AG, Interlaken, Switzerland

    collaborator UNKNOWN

  • Ospedale Regionale di Locarno

    lead OTHER

Principal Investigators

  • Luca Gabutti, MD · Ospedale Regionale di Locarno

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00718289 on ClinicalTrials.gov