Recruiting
Phase 2
Phase 3

Observational Study

Sponsor:

Biomedical Enterprises Inc

Code:

NCT01416896

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

End Stage Renal Disease

Study ID

NCT01416896

Start date

Aug, 2011

Status verified date

Aug, 2011

Completion date

Sep, 2012

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: New venous needle, the "BME needle"

Hemodialysis using the 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).

Interventions

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

Primary outcome measure

  • Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels [ Time Frame: 4 hours of hemodialysis ]

Central Contacts and Locations

Central contacts

Pedro A Jose, MD, PhD

202-476-5715pjose@cnmc.org

Locations

DaVita K Street Dialysis Center

Recruiting

Washington, District of Columbia, United States, 20037

Contacts

Pedro A Jose, MD, PhD

202-476-5715pjose@cnmc.org

Principal Investigator:

Pedro A Jose, Md, PhD

More Information

Sponsor

Biomedical Enterprises Inc

Last update posted

Aug 15, 2011

Last verified

Aug, 2011

Keywords

  • End stage Renal Disease
  • Hemodialysis
  • Oxidative Stress
  • Inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Biomedical Enterprises Inc on 2011-08-15.