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

This study has been completed.
Sponsor:
Collaborator:
Bichsel AG, Interlaken, Switzerland
Information provided by:
Ospedale Regionale di Locarno
ClinicalTrials.gov Identifier:
NCT00718289
First received: July 16, 2008
Last updated: July 17, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Haemodialysis
 Other: Citrate dialysate
Other: Acetate dialysate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Citrate- Versus Acetate-Based Dialysate in Bicarbonate Haemodialysis: Consequences on Haemodynamics, Coagulation, Acid-Base Status and Electrolytes

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dialysis
U.S. FDA Resources

Further study details as provided by Ospedale Regionale di Locarno:

Primary Outcome Measures:
  • Consequences on systemic haemodynamics [ Time Frame: Study duration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Consequences on coagulation, acid-base status, calcium balance and dialysis efficiency [ Time Frame: Study duration ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: March 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Citrate
Citrate dialysate for haemodialysis
 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]
Active Comparator: Acetate
Acetate dialysate
 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]

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic haemodialysis patients
  • dialysed 3 to 4 hours three times a week, who were
  • clinically stable and without intercurrent illnesses

Exclusion Criteria:

  • intercurrent illnesses
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718289

Locations
Switzerland
Ospedale Regionale di Locarno
Locarno, Ticino, Switzerland, 6600
Sponsors and Collaborators
Ospedale Regionale di Locarno
Bichsel AG, Interlaken, Switzerland
Investigators
Principal Investigator: Luca Gabutti, MD Ospedale Regionale di Locarno
  More Information

No publications provided by Ospedale Regionale di Locarno

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Luca Gabutti; Head of Department, Ospedale Regionale di Locarno
ClinicalTrials.gov Identifier: NCT00718289     History of Changes
Other Study ID Numbers: 012008
Study First Received: July 16, 2008
Last Updated: July 17, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by Ospedale Regionale di Locarno:
Citric acid
citrate
acetic acid
acetate
haemodialysis
 calcium
hypotension
haemodynamics
Dialysate for Haemodialysis

Additional relevant MeSH terms:
Citric Acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013