Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bnai Zion Medical Center | OTHER_GOV |
| Rivka Ziv Medical Center | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | large pore dialyzers (FX80, Fresenius, Germany) |
|
| 2 | Experimental | small pore dialyzers ( F8HPS, Fresenius, Germany) |
|
| A | Experimental | dialysate bicarbonate concentration of 33 mEq/l |
|
| B | Experimental | dialysate bicarbonate concentration of 40 mEq/l |
|
| I | Experimental | dialysate calcium concentration of 3 mEq/L |
|
| II | Experimental | dialysate calcium concentration of 2.5 mEq/L |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| large pore (FX80) compared to small pore dialyzer (F8HPS) | Device | Effect of pore size |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Dialysate Iron levels 2. Plasma levels of advanced oxidation protein products(AOPP) | Before HD, after 1 hour of HD with or without IV iron and at end of HD |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Tovbin, MD | Soroka University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HD unit in Department of Nephrology in Soroka Universty Medical Center | Beersheba | 84101 | Israel | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dialysate bicarbonate of 33 mEq/L compared to 40 mEq/L | Other | Effect of dialysate bicarbonate concentration |
|
| Dialysate calcium of 3 mEq/L compared to 2.5 mEq/L | Other | Effect of dialysate calcium concentration |
|
| HD unit in Bnai-zion Medical Center |
| Haifa |
| Israel |
| Rivka Ziv Medical center | Safed | Israel |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided