New Needle for Two-Needle Hemodialysis

Biomedical Enterprises Inc70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

Hemodialysis using the standard venous dialysis needle

Hemodialysis using a new venous needle, the "BME needle"PROCEDURE

Hemodialysis using a new venous dialysis needle or the "BME needle"

Hemodialysis using a new venous needle, the "BME needle"PROCEDURE

One hemodialysis using a new venous needle, the "BME needle"

Hemodialysis using the standard venous needlePROCEDURE

One hemodialysis using the standard venous needle

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

DaVita K Street Dialysis Center

Washington D.C., District of Columbia, United States

RECRUITING

Outcomes

Primary Outcomes

Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels

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.

Time frame: 4 hours of hemodialysis

Secondary Outcomes

Net change in oxidative stress and proinflammatory cytokines in plasma

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

Time frame: 4 hours hemodialysis

Central Contacts

Pedro A Jose, MD, PhD

CONTACT

202-476-5715 pjose@cnmc.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.