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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:
ClinicalTrials.gov Identifier:
NCT00718289
First Posted: July 18, 2008
Last Update Posted: July 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bichsel AG, Interlaken, Switzerland
Information provided by:
Ospedale Regionale di Locarno
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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:


Further study details as provided by Ospedale Regionale di Locarno:

Primary Outcome Measures:
  • Consequences on systemic haemodynamics [ Time Frame: Study duration ]

Secondary Outcome Measures:
  • Consequences on coagulation, acid-base status, calcium balance and dialysis efficiency [ Time Frame: Study duration ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 16, 2008
First Posted: July 18, 2008
Last Update Posted: July 18, 2008
Last Verified: July 2008

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
Dialysis Solutions
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions