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The purpose of this study is to determine if AAT-023 (Zuragen) solution is superior to Heparin in preventing Catheter Related Blood Stream Infections for End Stage Renal Disease patients.
The purpose of this study is to show that AAT-023 (Zuragen) Solution is superior to Heparin in preventing Catheter Related Blood Stream Infections (CRBSI) when used as a catheter lock solution in Central Venous Catheter's for Dialysis between hemodialysis treatments (3x per week), where CRBSI's are defined as concordant bacteria found in both the catheter and peripheral blood or the exit site and peripheral blood in subjects demonstrating a temperature greater than 38 degrees celcius.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAT-023 (Zuragen Arm) | Experimental | Active experimental consisting of AAT-023 (Zuragen)solution |
|
| Heparin | Active Comparator | 5000 units diluted with normal saline to the exact catheter lumen volume |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAT-023 solution (Zuragen) | Device | Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To show that AAT-023 (Zuragen) solution is superior to Heparin in preventing CRBSI when used as a catheter lock solution in CVCD's between hemodialysis treatments. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakersfield Dialysis Center | Bakersfield | California | 93309 | United States | ||
| Renal Medical Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21200319 | Derived | Maki DG, Ash SR, Winger RK, Lavin P; AZEPTIC Trial Investigators. A novel antimicrobial and antithrombotic lock solution for hemodialysis catheters: a multi-center, controlled, randomized trial. Crit Care Med. 2011 Apr;39(4):613-20. doi: 10.1097/CCM.0b013e318206b5a2. |
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| Heparin | Drug | Hepaarin 5000 units diluted with normal saline to the exact catheter lumen volume. |
|
| Lynwood |
| California |
| 90262 |
| United States |
| Nephrology & Hypertension Associates, PC | Middlebury | Connecticut | 06762 | United States |
| Brandon nephrology | Brandon | Florida | 33511 | United States |
| Gulf Breeze Dialysis Center | Dunedin | Florida | 34698 | United States |
| Bayonet Point Hudson Kidney Center | Hudson | Florida | 34667 | United States |
| Outcomes Research International, Inc. | Hudson | Florida | 34667 | United States |
| Bay Breeze Dialysis | Largo | Florida | 33778 | United States |
| New Port Richey Kidney Center | New Port Richey | Florida | 34668 | United States |
| Discovery Medical Research Group | Ocala | Florida | 34471 | United States |
| Nephrology consultants | Orlando | Florida | 32806 | United States |
| Hernando Kidney Center | Spring Hill | Florida | 34608 | United States |
| Nephrology Associates, P.C. | Augusta | Georgia | 30901 | United States |
| MId Atlantic Nephrology Associates, PA | Baltimore | Maryland | 21208 | United States |
| Caritas St. Elizabeth Center | Boston | Massachusetts | 02135 | United States |
| Western New England Renal & Transplant Associatea | Springfield | Massachusetts | 01107 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Hypertension & Renal Research Group | Buffalo | New York | 14225 | United States |
| Bayview Nephrology, Inc. | Erie | Pennsylvania | 16507 | United States |
| Kidney Associates, PLLC | Houston | Texas | 77030 | United States |
| Southwest Houston Research, LTD | Houston | Texas | 77099 | United States |
| Fox Valley Nephrology Associates | Appelton | Wisconsin | 54911 | United States |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007674 | Kidney Diseases |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D014570 | Urologic Diseases |
| 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 |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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