New Needle for Two-Needle Hemodialysis

Study Overview
=================
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.

Official Title
-----------------
New Needle for Two-Needle Hemodialysis

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* 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
* Procedure: Hemodialysis using the standard venous needle


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New venous needle, the BME needle<br>Hemodialysis using the new venous needle, the BME needle. | Procedure: Hemodialysis using a new venous needle, the BME needle<br>* Hemodialysis using a new venous dialysis needle or the BME needle<br>* Other names: The BME needle is a newly designed venous dialysis needle.;Procedure: Hemodialysis using a new venous needle, the BME needle<br>* One hemodialysis using a new venous needle, the BME needle<br>|
| Active Comparator: Standard venous needle, the standard needle<br>One hemodialysis using the standard venous needle, the standard needle (device). | Procedure: Hemodialysis using the standard venous needle<br>* Hemodialysis using the standard venous dialysis needle<br>* Other names: hemodialysis using the standard venous dialysis needle;Procedure: Hemodialysis using the standard venous needle<br>* One hemodialysis using the standard venous needle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 hours hemodialysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End stage Renal Disease, Hemodialysis, Oxidative Stress, Inflammation