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

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hemodialysis using the standard venous needle
Hemodialysis using a new venous needle, the "BME needle"
Hemodialysis using a new venous needle, the "BME needle"
Hemodialysis using the standard venous needle
Sponsored by
Biomedical Enterprises Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring End stage Renal Disease, Hemodialysis, Oxidative Stress, Inflammation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DaVita K Street Dialysis CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New venous needle, the "BME needle"

Standard venous needle, the "standard needle"

Arm Description

Hemodialysis using the new venous needle, the "BME needle".

One hemodialysis using the standard venous needle, the "standard needle" (device).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 9, 2011
Last Updated
August 12, 2011
Sponsor
Biomedical Enterprises Inc
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01416896
Brief Title
New Needle for Two-Needle Hemodialysis
Acronym
BME-1
Official Title
New Needle for Two-Needle Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Biomedical Enterprises Inc
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
End stage Renal Disease, Hemodialysis, Oxidative Stress, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
New venous needle, the "BME needle"
Arm Type
Experimental
Arm Description
Hemodialysis using the new venous needle, the "BME needle".
Arm Title
Standard venous needle, the "standard needle"
Arm Type
Active Comparator
Arm Description
One hemodialysis using the standard venous needle, the "standard needle" (device).
Intervention Type
Procedure
Intervention Name(s)
Hemodialysis using the standard venous needle
Other Intervention Name(s)
hemodialysis using the standard venous dialysis needle
Intervention Description
Hemodialysis using the standard venous dialysis needle
Intervention Type
Procedure
Intervention Name(s)
Hemodialysis using a new venous needle, the "BME needle"
Other Intervention Name(s)
The "BME needle" is a newly designed venous dialysis needle.
Intervention Description
Hemodialysis using a new venous dialysis needle or the "BME needle"
Intervention Type
Procedure
Intervention Name(s)
Hemodialysis using a new venous needle, the "BME needle"
Intervention Description
One hemodialysis using a new venous needle, the "BME needle"
Intervention Type
Procedure
Intervention Name(s)
Hemodialysis using the standard venous needle
Intervention Description
One hemodialysis using the standard venous needle
Primary Outcome Measure Information:
Title
Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels
Description
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 Outcome Measure Information:
Title
Net change in oxidative stress and proinflammatory cytokines in plasma
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro A Jose, MD, PhD
Phone
202-476-5715
Email
pjose@cnmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo R Zarate, MD
Organizational Affiliation
Biomedical Enterprises Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro A Jose, MD, PhD
Organizational Affiliation
Children National Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaVita K Street Dialysis Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro A Jose, MD, PhD
Phone
202-476-5715
Email
pjose@cnmc.org
First Name & Middle Initial & Last Name & Degree
Pedro A Jose, Md, PhD

12. IPD Sharing Statement

Links:
URL
http://www.bmedialysis.com
Description
Related Info

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