New Needle for Two-Needle Hemodialysis

Phase 2

• Conditions: End Stage Renal Disease
• Interventions: Procedure: Hemodialysis using a new venous needle, the "BME needle"; Procedure: Hemodialysis using the standard venous needle

• Registration Number: NCT01416896
• Lead Sponsor: Biomedical Enterprises Inc

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study Start: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-12
• Last Update Submitted: 2011-08-12
• Study First Posted: 2011-08-15
• Last Update Posted: 2011-08-15
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
New venous needle, the "BME needle"	Hemodialysis using a new venous needle, the "BME needle"	Hemodialysis using the new venous needle, the "BME needle".
Standard venous needle, the "standard needle"	Hemodialysis using the standard venous needle	One hemodialysis using the standard venous needle, the "standard needle" (device).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

DaVita K Street Dialysis Center; 🇺🇸 Washington, District of Columbia, United States