Removal of Ligand-bound Iron During Intravenous (IV) Iron Administration in Hemodialysis (HD)
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Purpose
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 |
|---|---|
|
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: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Removal of Ligand-bound Iron During Intravenous Iron Administration in Hemodialysis by Large Pore Dialyzers |
- 1. Dialysate Iron levels 2. Plasma levels of advanced oxidation protein products(AOPP) [ Time Frame: Before HD, after 1 hour of HD with or without IV iron and at end of HD ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | March 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
large pore dialyzers (FX80, Fresenius, Germany)
|
Device: large pore (FX80) compared to small pore dialyzer (F8HPS)
Effect of pore size
|
|
Experimental: 2
small pore dialyzers ( F8HPS, Fresenius, Germany)
|
Device: large pore (FX80) compared to small pore dialyzer (F8HPS)
Effect of pore size
|
|
Experimental: A
dialysate bicarbonate concentration of 33 mEq/l
|
Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L
Effect of dialysate bicarbonate concentration
|
|
Experimental: B
dialysate bicarbonate concentration of 40 mEq/l
|
Other: Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L
Effect of dialysate bicarbonate concentration
|
|
Experimental: I
dialysate calcium concentration of 3 mEq/L
|
Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L
Effect of dialysate calcium concentration
|
|
Experimental: II
dialysate calcium concentration of 2.5 mEq/L
|
Other: Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L
Effect of dialysate calcium concentration
|
Detailed Description:
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
- Iron removal assessing dialysate iron levels.
- Effect of iron removal and it's associated experimental conditions on patient status, assessing plasma AOPP levels and inflammation related parameters
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
- Low to high dialysate calcium concentrations concentration (using uniform dialysate bicarbonate of 33 mEq/L)
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.
Eligibility| Ages Eligible for Study: | 18 Years to 88 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chronic hemodialysis patients
Exclusion Criteria:
- Acute disease (infection, thrombosis, ischemia, bleeding) Hepatitis B, Hepatitis C or HIV
- Intravenous iron administration or packed red cell transfusion in the last 3 weeks prior to the study
- Refusal to comply with limitations in fat containing food during HD with plasma sampling for AOPP evaluation
Contacts and Locations| Israel | |
| HD unit in Department of Nephrology in Soroka Universty Medical Center | |
| Beer-sheva, Israel, 84101 | |
| HD unit in Bnai-zion Medical Center | |
| Haifa, Israel | |
| Rivka Ziv Medical center | |
| Zefat, Israel | |
| Principal Investigator: | David Tovbin, MD | Soroka University Medical Center |
More Information
No publications provided
| Responsible Party: | David Tovbin MD, Soroka University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00638300 History of Changes |
| Other Study ID Numbers: | sor421306ctil |
| Study First Received: | March 12, 2008 |
| Last Updated: | July 11, 2010 |
| Health Authority: | Israel: Institutional Review Board |
Keywords provided by Soroka University Medical Center:
|
hemodialysis iron inflammation atomic absorption dialysate advanced oxidation protein products |
large pore dialysate bicarbonate calcium citrate ligand |
Additional relevant MeSH terms:
|
Calcium, Dietary Iron Bone Density Conservation Agents Physiological Effects of Drugs |
Pharmacologic Actions Trace Elements Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013