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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00756964 |
Acute kidney injury is associated with a rise in serum uric acid during cardiovascular surgery and can cause poor blood flow to the kidneys making them vulnerable to kidney injury. We hypothesize that hyperuricemia, particularly if chronic and marked, is a risk factor for acute kidney injury. The preoperative lowering of serum uric acid will reduce the incidence of acute kidney injury following cardiovascular surgery.
Condition | Intervention | Phase |
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Hyperuricemia |
Drug: Rasburicase Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Rasburicase on Acute Kidney Injury, Kidney Function, the Incidence of Renal Replacement Therapy and All-Cause Mortality Following Cardiac Surgery. |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Study Drug: Active Comparator |
Drug: Rasburicase
Rasburicase (7.5mg in 50ml of NS over 30 minutes) or identical placebo will be administered as an intravenous infusion preoperatively.
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Control: Placebo Comparator |
Drug: Placebo
The intravenous bags containing rasburicase and placebo drug will be color-coded to appear identical. These will be provided free of cost to the patients.
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The study will be a prospective, double-blind, placebo-controlled, randomized, clinical trial, initiated and implemented conjointly by the Nephrology and Cardiovascular Surgery Departments at Shands Hospital at the University of Florida in Gainesville, FL. We propose to study whether lowering uric acid provides significant renal and cardiovascular protection in subjects undergoing cardiovascular surgery. Up to 30 patients presenting for elective or urgent CV surgery with uric acid level > 6.5 mg/dl and estimated glomerular filtration of 30 - 60 ml/min will be included in the study. Patients recruitment will continue until up to 30 patients have completed the study, taking into account expected patient loss due to withdrawal of consent, incomplete study and other reasons. Patients will be randomized to a control group or rasburicase group. Rasburicase or identical placebo will be administered to each group after randomization. A selected number of patients may undergo additional testing for mechanistic (non-clinical) secondary endpoints.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Undergoing elective cardiothoracic surgery(s), alone or in combination with other procedures/surgery(s):
thoracic aortic aneurysm, cardiac valves, coronary artery bypass grafting, abdominal thoracic aneurysm, other CV surgery, and
Exclusion Criteria:
Contact: A. Ahsan Ejaz, MD | 352-273-5328 | ejazaa@medicine.ufl.edu |
Contact: Thomas M Beaver, MD | 352-273-5503 | beavetm@surgery.ufl.edu |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32610 | |
Contact: A. Ahsan Ejaz, MD 352-273-5328 ejazaa@medicine.ufl.edu | |
Contact: Thomas M Beaver, MD 352-273-5503 beavetm@surgery.ifl.edu | |
Principal Investigator: Thomas M Beaver, MD | |
Sub-Investigator: Richard J Johnson, MD | |
Sub-Investigator: Tomas M Martin, MD | |
Sub-Investigator: Puneet Sood, MD | |
Sub-Investigator: Charles T Klodell, MD | |
Sub-Investigator: Mohamed Shafiu, MD | |
Sub-Investigator: Philip J Hess, MD | |
Sub-Investigator: Vijay Lingegowda, MD | |
Sub-Investigator: Maria Rojas, MD | |
Sub-Investigator: Alejandro Paya, MD | |
Sub-Investigator: Bhagwan Dass, MD | |
Sub-Investigator: Gurgit S Dhatt, MD | |
Sub-Investigator: Chirag Faldu, MD | |
Sub-Investigator: Al-paradis Dana, MD |
Principal Investigator: | A. Ahsan Ejaz, MD | University of Florida |
Responsible Party: | University of Florida ( A. Ahsan Ejaz, M.D. ) |
Study ID Numbers: | WIRB 20081132 |
Study First Received: | September 19, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00756964 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cardiac surgery hyperuricemia |
Uric Acid Hyperuricemia Antirheumatic Agents Rasburicase |
Pathologic Processes Therapeutic Uses Hyperuricemia Antirheumatic Agents |
Gout Suppressants Rasburicase Pharmacologic Actions |