New Needle for Two-Needle Hemodialysis

End Stage Renal Disease Clinical Trial

— BME-1  

Official title:

New Needle for Two-Needle Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01416896
• Other study ID #: BME-1
• Secondary ID: R44DK059062
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 9, 2011
• Last updated: August 12, 2011
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2011
• Source: Biomedical Enterprises Inc
• Contact: Pedro A Jose, MD, PhD
• Phone: 202-476-5715
• Email: pjose[@]cnmc.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• Hemodialysis using the standard venous needle
Hemodialysis using the standard venous dialysis needle
• Hemodialysis using a new venous needle, the "BME needle"
Hemodialysis using a new venous dialysis needle or the "BME needle"
• Hemodialysis using a new venous needle, the "BME needle"
One hemodialysis using a new venous needle, the "BME needle"
• Hemodialysis using the standard venous needle
One hemodialysis using the standard venous needle

Locations

Country	Name	City	State
United States	DaVita K Street Dialysis Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Biomedical Enterprises Inc	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours of hemodialysis	No
Secondary	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	4 hours hemodialysis	No

External Links

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