New Needle for Two-Needle Hemodialysis (BME-1)
This study is currently recruiting participants.
Verified August 2011 by Biomedical Enterprises Inc
Sponsor:
Biomedical Enterprises Inc
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
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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" 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
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:
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 Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013