New Needle for Two-Needle Hemodialysis (BME-1)

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 Overview

• Status: Unknown
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Procedure: Hemodialysis using a new venous needle, the "BME needle"; Procedure: Hemodialysis using a new venous needle, the "BME needle"; Procedure: Hemodialysis using the standard venous needle; Procedure: Hemodialysis using the standard venous needle

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Pedro A Jose, MD, PhD; Phone Number: 202-476-5715; Email: pjose@cnmc.org

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Recruiting
      • DaVita K Street Dialysis Center
      • Contact: Pedro A Jose, MD, PhD; Phone Number: 202-476-5715; Email: pjose@cnmc.org
      • Principal Investigator: Pedro A Jose, Md, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New venous needle, the "BME needle"; Hemodialysis using the new venous needle, the "BME needle".	Procedure: Hemodialysis using a new venous needle, the "BME needle"; Hemodialysis using a new venous dialysis needle or the "BME needle"; Other Names: The "BME needle" is a newly designed venous dialysis needle.; Procedure: Hemodialysis using a new venous needle, the "BME needle"; One hemodialysis using a new venous needle, the "BME needle"
Active Comparator: Standard venous needle, the "standard needle"; One hemodialysis using the standard venous needle, the "standard needle" (device).	Procedure: Hemodialysis using the standard venous needle; Hemodialysis using the standard venous dialysis needle; Other Names: hemodialysis using the standard venous dialysis needle; Procedure: Hemodialysis using the standard venous needle; One hemodialysis using the standard venous needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biomedical Enterprises Inc
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Alfredo R Zarate, MD, Biomedical Enterprises Inc; Principal Investigator: Pedro A Jose, MD, PhD, Children National Medical Center

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 12, 2011
• First Posted (Estimate): August 15, 2011

Study Record Updates

• Last Update Posted (Estimate): August 15, 2011
• Last Update Submitted That Met QC Criteria: August 12, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Inflammation; Oxidative Stress; Hemodialysis; End stage Renal Disease
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: BME-1; R44DK059062 (U.S. NIH Grant/Contract)