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| ID | Type | Description | Link |
|---|---|---|---|
| R44DK059062 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New venous needle, the "BME needle" | Experimental | Hemodialysis using the 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemodialysis using the standard venous needle | Procedure | Hemodialysis using the standard venous dialysis needle |
|
| 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 |
| 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 |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro A Jose, MD, PhD | Contact | 202-476-5715 | pjose@cnmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Alfredo R Zarate, MD | Biomedical Enterprises Inc | Principal Investigator |
| Pedro A Jose, MD, PhD | Children National Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita K Street Dialysis Center | Recruiting | Washington D.C. | District of Columbia | 20037 | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Hemodialysis using a new venous needle, the "BME needle" | Procedure | Hemodialysis using a new venous dialysis needle or the "BME needle" |
|
|
| Hemodialysis using a new venous needle, the "BME needle" | Procedure | One hemodialysis using a new venous needle, the "BME needle" |
|
| Hemodialysis using the standard venous needle | Procedure | One hemodialysis using the standard venous needle |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |