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Patients with Stage 3B, 4,or 5 Chronic Kidney Disease who are to undergo an angiography procedure with contrast agent will be asked if they are willing to join the trial. If so they will be screened and randomized to receive either sodium bicarbonate or saline before, during and after the contrast media is given. They will be asked for serum samples 1 to 3 days, 7, 30, 90 and 180 days after the procedure to evaluate whether the sodium bicarbonate has reduced the incidence of contrast induced chronic kidney disease by measuring their serum creatinine, as well as whether they have required renal dialysis or other renal replacement therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline infusion | Active Comparator | Saline will be given as an active control agent to compare with sodium bicarbonate. Each bag of solution will be blinded, and given in the same manner. |
|
| Sodium Bicarbonate | Experimental | Infusion of sodium bicarbonate will be given prior to,during and after the contrast agent for a total of 6 to 10 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium bicarbonate | Drug | Serum creatinine will be measured on Days 3,7, 30, 90, and 180 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death or renal replacement therapy or sustained kidney injury | Sustained kidney injury is two sequential 20% reduction of eGFR from baseline as calculated from change in sertum creatinine at least three weeks after receiving IP. | Over six months following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| A comparison between the treatments for length of hospital stay, post contrast. | Over six months after the treatment | |
| A comparison between the treatments of the time to renal replacement therapy (any type) or death (whichever occurs first) over the 6-month observation period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osceola Regional Medical Center | Kissimmee | Florida | 34741 | United States | ||
| Northside Hospital |
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| six months after receiving IP |
| St. Petersburg |
| Florida |
| 33709 |
| United States |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | United States |
| St. Johns Hospital | Springfield | Illinois | 62701 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States |
| St Luke's Health System | Kansas City | Missouri | 64111 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Mt Sinai School of Medcine | New York | New York | 10029 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | United States |
| The Christ Hospital | Cincinnati | Ohio | United States |
| St Luke's Heart and Vascular Center | Bethlehem | Pennsylvania | 18015 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| The Miriam Hospital (Lifespan) | Providence | Rhode Island | 02906 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75227 | United States |
| Fletcher Allen Hospital | Burlington | Vermont | 05401 | United States |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| 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 |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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