NCT00718289|CompletedPhase 4
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Sponsor study identifier
interventional
25
1 country
1
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2007
Actual (reported)Study Completion
November 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2007
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 2007
Actual (reported)November 2007
Actual (reported)July 16, 2008
Actual (reported)July 18, 2008
Actual (reported)Consequences on systemic haemodynamics
Study duration
Consequences on coagulation, acid-base status, calcium balance and dialysis efficiency
Study duration
Citrate dialysate for haemodialysis
Acetate dialysate
dialysis fluid composition for Citrate (C) and Acetate (A): acetate \[3.0 mmol/L in A and 0.3 in C\], citrate \[0 mmol/L in A and 0.8 in C\]
dialysis fluid composition for Citrate (C) and Acetate (A): acetate \[3.0 mmol/L in A and 0.3 in C\], citrate \[0 mmol/L in A and 0.8 in C\]
Ospedale Regionale di Locarno
Locarno, Canton Ticino, 6600, Switzerland
Gabutti L, Lucchini B, Marone C, Alberio L, Burnier M. Citrate- vs. acetate-based dialysate in bicarbonate haemodialysis: consequences on haemodynamics, coagulation, acid-base status, and electrolytes. BMC Nephrol. 2009 Mar 5;10:7. doi: 10.1186/1471-2369-10-7.
Luca Gabutti, MD
Ospedale Regionale di Locarno
25 participants (actual enrollment reported by the registry).
First Submitted
July 16, 2008
First Posted
July 18, 2008
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
November 2007
Actual (reported)Study Completion
November 2007
Actual (reported)Last Updated
July 18, 2008
Record last verified: 2008-07
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Source: ClinicalTrials.gov.
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