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

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ClinicalTrials.gov Identifier: NCT00718289
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : July 18, 2008
Sponsor:
Collaborator:
Bichsel AG, Interlaken, Switzerland
Information provided by:
Ospedale Regionale di Locarno

Brief 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.


Condition or disease Intervention/treatment Phase
Haemodialysis Other: Citrate dialysate Other: Acetate dialysate Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : March 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arm Intervention/treatment
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]



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

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


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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

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

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 Posted: July 18, 2008    Key Record Dates
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