Effect of Parenteral Iron Therapy on Inflammatory Response and Oxidative Stress Chronic Hemodialysis
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2007 |
| End Date: | January 2009 |
| Contact: | Burl R Don, MD |
| Email: | br.don@ucdmc.ucdavis.edu |
| Phone: | 916-734-7961 |
The Effect of Parenteral Iron Therapy on the Systemic Inflammatory Response and Oxidative Stress in Chronic Hemodialysis Patients
Parenteral iron therapy is now commonly administered to dialysis patients with the majority
of patients receiving this therapy as part of the treatment for their anemia. Although
intravenous iron has improved clinical response to recombinant erythropoietin, there is a
concern that iron therapy may have deleterious effects in Chronic Kidney Disease (CKD)
patients. Iron can damage tissues by catalyzing the conversion of hydrogen peroxide to
free-radical ions that attack cellular proteins, DNA and membranes as part of oxidative
stress. Numerous in vitro studies have shown tissue toxicity from iron and increased
infectious potential. Oxidative stress can also lead to activation of the systemic
inflammatory response with the release of a number of key cytokines and growth factors.
There is now a link between inflammation, oxidative stress and acceleration of vascular
disease in both patients with normal as well as reduced renal function. In a study comparing
normal versus low hematocrit levels in hemodialysis patients, mortality was higher in the
normal hematocrit group. The major difference between the two groups has been attributed to
the fact that patients in the normal hematocrit group received significantly more iron than
the patients with low hematocrit. There was a 2.4 fold greater mortality rate in patients
receiving parenteral iron.
The effect of parenteral iron administration on activation of the systemic inflammatory
response in hemodialysis patients has not been evaluated. The purpose of this study is to
measure a number of key cytokines, inflammatory and oxidative stress markers in hemodialysis
patients receiving iron repletion therapy as part of their standard care.
of patients receiving this therapy as part of the treatment for their anemia. Although
intravenous iron has improved clinical response to recombinant erythropoietin, there is a
concern that iron therapy may have deleterious effects in Chronic Kidney Disease (CKD)
patients. Iron can damage tissues by catalyzing the conversion of hydrogen peroxide to
free-radical ions that attack cellular proteins, DNA and membranes as part of oxidative
stress. Numerous in vitro studies have shown tissue toxicity from iron and increased
infectious potential. Oxidative stress can also lead to activation of the systemic
inflammatory response with the release of a number of key cytokines and growth factors.
There is now a link between inflammation, oxidative stress and acceleration of vascular
disease in both patients with normal as well as reduced renal function. In a study comparing
normal versus low hematocrit levels in hemodialysis patients, mortality was higher in the
normal hematocrit group. The major difference between the two groups has been attributed to
the fact that patients in the normal hematocrit group received significantly more iron than
the patients with low hematocrit. There was a 2.4 fold greater mortality rate in patients
receiving parenteral iron.
The effect of parenteral iron administration on activation of the systemic inflammatory
response in hemodialysis patients has not been evaluated. The purpose of this study is to
measure a number of key cytokines, inflammatory and oxidative stress markers in hemodialysis
patients receiving iron repletion therapy as part of their standard care.
Study Design
Patients who have been prescribed iron repletion therapy (100 mg IV every dialysis treatment
for ten treatments) by their primary nephrologist will be recruited for the study. Baseline
blood samples will be obtained before and after each dialysis treatment for two dialysis
treatments prior to the administration of iron. On the day of dialysis that iron therapy is
started, blood samples will be obtained before and after the dialysis treatment via the
patient's vascular access. This procedure will be repeated each dialysis treatment for the
ten sessions during which the patient is receiving intravenous iron. Subsequently,
pre-dialysis blood samples will be obtained every week for four weeks after the
administration of intravenous iron has been completed
Patients who have been prescribed iron repletion therapy (100 mg IV every dialysis treatment
for ten treatments) by their primary nephrologist will be recruited for the study. Baseline
blood samples will be obtained before and after each dialysis treatment for two dialysis
treatments prior to the administration of iron. On the day of dialysis that iron therapy is
started, blood samples will be obtained before and after the dialysis treatment via the
patient's vascular access. This procedure will be repeated each dialysis treatment for the
ten sessions during which the patient is receiving intravenous iron. Subsequently,
pre-dialysis blood samples will be obtained every week for four weeks after the
administration of intravenous iron has been completed
Inclusion Criteria:
- Hemodialysis patients age 18 or greater who are prescribed parenteral iron by their
primary nephrologist
We found this trial at
1
site
Click here to add this to my saved trials
