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Sponsored by: |
Soroka University Medical Center |
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Information provided by: | Soroka University Medical Center |
ClinicalTrials.gov Identifier: | NCT00638300 |
The study's hypothesis is that HD with large pore dialyzers remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.
Condition | Intervention |
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Hemodialysis Patients |
Device: large pore (FX80) compared to small pore dialyzer (F8HPS) Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment |
Official Title: | Removal of Ligand-Bound Iron During Intravenous Iron Administration in Hemodialysis by Large Pore Dialyzers |
Estimated Enrollment: | 30 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
large pore dialyzers (FX80, Fresenius, Germany)
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Device: large pore (FX80) compared to small pore dialyzer (F8HPS)
Effect of pore size
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2: Experimental
small pore dialyzers ( F8HPS, Fresenius, Germany)
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Device: large pore (FX80) compared to small pore dialyzer (F8HPS)
Effect of pore size
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A: Experimental
dialysate bicarbonate concentration of 33 mEq/l
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Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L
Effect of dialysate bicarbonate concentration
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B: Experimental
dialysate bicarbonate concentration of 40 mEq/l
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Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L
Effect of dialysate bicarbonate concentration
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I: Experimental
dialysate calcium concentration of 3 mEq/L
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Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L
Effect of dialysate calcium concentration
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II: Experimental
dialysate calcium concentration of 2.5 mEq/L
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Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L
Effect of dialysate calcium concentration
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Most hemodialysis(HD) patients receive during HD intravenous iron compounds, which are composed of an iron core and a sugar polymer shell. A small percentage of iron from the iron compound is released to the plasma, and may be associated with increased oxidative stress and protein oxidation. The study's hypothesis is that HD with large pore dialyzers may remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis. Ligand-bound iron removal is also hypothesized to be affected by dialysate calcium and bicarbonate concentrations, which may affect iron-ligand binding.
Study Specific aims are:
To evaluate
Study include 3 parts
Comparing large to small pore dialyzers
(To achieve baseline uniform conditions, patients will be on uniform dialysate bicarbonate and calcium concentrations of 33 mEq/L and 3 mEq/L,respectively, using large pore dialyzers during this part, besides the 2 HD sessions evaluating low pore dialyzers)
and after few week break
Using large pore dialyzers to compare
Low to high dialysate bicarbonate concentration (using uniform dialysate calcium concentrations of 3 mEq/L)
and after few week break
In each part, patients will be first evaluated in HD without IV iron administration, which will serve as a control for evaluation after a week in HD with IV iron administration.
In each part, patients will be randomized to start either with one of the 2 experimental conditions, and after 1 week without evaluation will cross-over to the other experimental condition.
Patients may participate in 1,2 or the 3 parts of study depending on their will and condition.
Ages Eligible for Study: | 18 Years to 88 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Tovbin, MD | 972-54-296579 | dtovbin@bgu.ac.il |
Israel | |
HD unit in Department of Nephrology in Soroka Universty Medical Center | Recruiting |
Beer-sheva, Israel, 84101 | |
Contact: David Tovbin, MD 972-544-296579 dtovbin@bgu.ac.il | |
Principal Investigator: David Tovbin, MD | |
HD unit in Bnai-zion Medical Center | Not yet recruiting |
Haifa, Israel | |
Contact: Shimon Storch, MD 972-506267258 shimon.storch@b-zion.org.il | |
Principal Investigator: Shimon Storch, MD |
Principal Investigator: | David Tovbin, MD | Soroka University Medical Center |
Study ID Numbers: | sor421306ctil |
Study First Received: | March 12, 2008 |
Last Updated: | March 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00638300 History of Changes |
Health Authority: | Israel: Institutional Review Board |
hemodialysis iron inflammation atomic absorption dialysate advanced oxidation protein products |
large pore dialysate bicarbonate calcium citrate ligand |
Calcium, Dietary Citric Acid Citrate Iron Inflammation |