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| Sponsors and Collaborators: |
Ospedale Regionale di Locarno Bichsel AG, Interlaken, Switzerland |
|---|---|
| Information provided by: | Ospedale Regionale di Locarno |
| ClinicalTrials.gov Identifier: | NCT00718289 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Citrate- Versus Acetate-Based Dialysate in Bicarbonate Haemodialysis: Consequences on Haemodynamics, Coagulation, Acid-Base Status and Electrolytes |
| 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 |
|---|---|
|
Citrate: Experimental
Citrate dialysate for haemodialysis
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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]
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Acetate: Active Comparator
Acetate dialysate
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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]
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Switzerland, TICINO | |
| Ospedale Regionale di Locarno | |
| Locarno, TICINO, Switzerland, 6600 | |
| Principal Investigator: | Luca Gabutti, MD | Ospedale Regionale di Locarno |
More Information
| Responsible Party: | Ospedale Regionale di Locarno ( Luca Gabutti; Head of Department ) |
| Study ID Numbers: | 012008 |
| Study First Received: | July 16, 2008 |
| Last Updated: | July 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00718289 History of Changes |
| Health Authority: | Switzerland: Swissmedic |
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Citric acid citrate acetic acid acetate haemodialysis |
calcium hypotension haemodynamics Dialysate for Haemodialysis |
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Hypotension Calcium, Dietary Anticoagulants |
Citric Acid Retinol acetate Chelating Agents |
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Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Citric Acid Chelating Agents Pharmacologic Actions |
