End Stage Renal Disease
Conditions
Keywords
End stage Renal Disease, Hemodialysis, Oxidative Stress, Inflammation
Brief summary
Our preliminary studies have demonstrated that an innovative new design of the hemodialysis venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the patient) with three jets is superior to the standard venous needle because it decreases the velocity and turbulence of the blood when compared with the standard venous needle, it is more efficient in the removal of toxins from the blood, and it is safe and effective. More importantly, our preliminary studies suggested that the new needle causes less damage to the dialysis vascular access and to circulating blood cells and less inflammation and oxidative stress. These will decrease medical complications, the high cost of care and death in dialysis patients. The current study will corroborate the finding of previous studies.
Interventions
PROCEDUREHemodialysis using the standard venous needle
Hemodialysis using the standard venous dialysis needle
PROCEDUREHemodialysis using a new venous needle, the BME needle
Hemodialysis using a new venous dialysis needle or the BME needle
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Biomedical Enterprises Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(1) end stage renal disease receiving hemodialysis in an ambulatory outpatient dialysis facility (2) male or female, (3) ages 18-80, (4) arterio-venous graft or AV fistula as vascular access,
Exclusion criteria
patients with fever, infection, inflammation or malignancy will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels | 4 hours of hemodialysis | The net change in the levels of intracellular IL-6, IL-6 soluble receptor, IL-6 gp130, superoxide, H2O2 and IL-1 during dialysis (difference between pre and post dialysis) using the new venous needle will be compared with the change using the current venous needle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Net change in oxidative stress and proinflammatory cytokines in plasma | 4 hours hemodialysis | The net change in the plasma levels of IL-1, IL-6, MDA and AOPP during dialysis (difference between pre and post dialysis) using the new venous needle will be compared with the net change that occurs in patients using the current venous needle |
Countries
United States
Contacts
Primary ContactPedro A Jose, MD, PhD
Outcome results
None listed