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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Biomedical Enterprises Inc.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Biomedical Enterprises Inc
ClinicalTrials.gov Identifier:
NCT01416896
First received: August 9, 2011
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
Procedure: Hemodialysis using the standard venous needle
Procedure: Hemodialysis using a new venous needle, the "BME needle"
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: New Needle for Two-Needle Hemodialysis

Resource links provided by NLM:


Further study details as provided by Biomedical Enterprises Inc:

Primary Outcome Measures:
  • Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels [ Time Frame: 4 hours of hemodialysis ] [ Designated as safety issue: No ]
    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:
  • Net change in oxidative stress and proinflammatory cytokines in plasma [ Time Frame: 4 hours hemodialysis ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 70
Study Start Date: August 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: hemodialysis using the standard venous dialysis needle
Procedure: Hemodialysis using the standard venous needle
One hemodialysis using the standard venous needle

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416896

Contacts
Contact: Pedro A Jose, MD, PhD 202-476-5715 pjose@cnmc.org

Locations
United States, District of Columbia
DaVita K Street Dialysis Center Recruiting
Washington, District of Columbia, United States, 20037
Contact: Pedro A Jose, MD, PhD    202-476-5715    pjose@cnmc.org   
Principal Investigator: Pedro A Jose, Md, PhD         
Sponsors and Collaborators
Biomedical Enterprises Inc
Investigators
Principal Investigator: Alfredo R Zarate, MD Biomedical Enterprises Inc
Principal Investigator: Pedro A Jose, MD, PhD Children National Medical Center
  More Information

Additional Information:
na  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Alfredo Zarate, MD, Biomedical Enterprises Inc.
ClinicalTrials.gov Identifier: NCT01416896     History of Changes
Other Study ID Numbers: BME-1, R44DK059062
Study First Received: August 9, 2011
Last Updated: August 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Biomedical Enterprises Inc:
End stage Renal Disease
Hemodialysis
Oxidative Stress
Inflammation

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014