New Needle for Two-Needle Hemodialysis

NCT01416896 | Unknown Phase 2 DMC

• 2 other identifiers: BME-1R44DK059062
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

End stage Renal Disease; Hemodialysis; Oxidative Stress; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Net change in oxidative stress and proinflammatory cytokines in plasma

  4 hours hemodialysis

Study Arms (2)

New venous needle, the "BME needle"

EXPERIMENTAL

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

Procedure: Hemodialysis using a new venous needle, the "BME needle"

Standard venous needle, the "standard needle"

ACTIVE COMPARATOR

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

Procedure: Hemodialysis using the standard venous needle

Interventions

Hemodialysis using the standard venous needle PROCEDURE

Hemodialysis using the standard venous dialysis needle

Also known as: hemodialysis using the standard venous dialysis needle

Standard venous needle, the "standard needle"

Hemodialysis using a new venous needle, the "BME needle" PROCEDURE

Hemodialysis using a new venous dialysis needle or the "BME needle"

Also known as: The "BME needle" is a newly designed venous dialysis needle.

New venous needle, the "BME needle"

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Biomedical Enterprises Inc: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

DaVita K Street Dialysis Center

Washington D.C., District of Columbia, 20037, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alfredo R Zarate, MD

  Biomedical Enterprises Inc

  PRINCIPAL INVESTIGATOR

• Pedro A Jose, MD, PhD

  Children National Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro A Jose, MD, PhD

CONTACT

202-476-5715; pjose@cnmc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 15, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 15, 2011

Record last verified: 2011-08

Locations

US (1)