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Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. This study aims to enroll patients with increased risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will be randomized to either RenalGuard therapy or standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Therapy | Active Comparator | Standard of care for patients at risk of CIN |
|
| RenalGuard Therapy | Experimental | Induced Diuresis with Matched Replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RenalGuard Therapy | Device | Induced Diuresis with matched replacement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Contrast Induced Nephropathy | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events | 90 days | |
| Mean peak increase in serum creatinine post contrast administration | 72 hours | |
| Proportion of patients who develop CIN at 7 days post contrast administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Davidson, MD | Northwestern University | Principal Investigator |
| Richard Solomon, MD | University of Vermont | Principal Investigator |
| Roxana Mehran, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35924 | United States | ||
| Torrance Medical Center |
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| Standard Therapy |
| Drug |
Standard of care for patients at risk of CIN |
|
| 7 days |
| Proportion of patients who maintain a rise in serum creatinine at 7 days | 7 days |
| Torrance |
| California |
| 90505 |
| United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Clearwater Cardiovascular | Clearwater | Florida | 33756 | United States |
| University of Florida | Jacksonville | Florida | 32209 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Advocate Good Samaritan | Downers Grove | Illinois | 60515 | United States |
| Advocate Health | Naperville | Illinois | 65040 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21218 | United States |
| St. Elizabeth's Hospital | Brighton | Massachusetts | 02135 | United States |
| Cape Cod Healthcare | Hyannis | Massachusetts | 02601 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| Northern Michigan Hospital | Petoskey | Michigan | 49770 | United States |
| Abbott Northwestern | Minneapolis | Minnesota | 55407 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| St. Joseph Medical Center | Saint Charles | Missouri | 63301 | United States |
| NYU Medical Center | New York | New York | 10016 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Montefiore Medical Center | New York | New York | 10467 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Rex Hospital | Raleigh | North Carolina | 27607 | United States |
| St. John Research Institute | Bartlesville | Oklahoma | 74006 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Guthrie Medical Center | Sayre | Pennsylvania | 18840 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Austin Heart Central | Austin | Texas | 78756 | United States |
| Baylor Scott & White | Plano | Texas | 75093 | United States |
| Austin Heart Round Rock | Round Rock | Texas | 78681 | United States |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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