Lowering Serum Uric Acid to Prevent Acute Kidney Injury (RasbAKI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00756964
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : September 3, 2012
Last Update Posted : September 3, 2012
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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 or disease Intervention/treatment Phase
Hyperuricemia Drug: Rasburicase Drug: Placebo Phase 2

Detailed Description:

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 cardiovascular 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Rasburicase on Acute Kidney Injury, Kidney Function, the Incidence of Renal Replacement Therapy and All-cause Mortality Following Cardiac Surgery.
Study Start Date : October 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Rasburicase
patients receiving rasburicase to lower serum uric acid
Drug: Rasburicase
Rasburicase (Dose: 7.5mg in 50ml of normal saline administered over 30 minutes) or identical placebo will be administered as an (dosage form)intravenous infusion preoperatively.
Other Name: urate oxidase enzyme
Placebo Comparator: Placebo
patients will receive a placebo
Drug: Placebo
Placebo drug (color-coded to appear identical to study drug) administered as an (dosage form) intravenous infusion preoperatively.
Other Name: inactive ingredient

Primary Outcome Measures :
  1. Number of Patients With Acute Kidney Injury (AKI). [ Time Frame: Within 48 hours postoperatively ]
    Acute kidney injury will be defined as an increase in serum creatinine of 0.3mg/dL from baseline or a 50% increase in serum creatinine from baseline values within 48 hours after surgery.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 years or older, and
  2. 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
  3. Preoperative serum uric acid > 6.5 mg/dL, and
  4. Preoperative estimated glomerular filtration rate of >30ml/min/1.73m2 or higher, but less than 60ml/min/1.73m2

Exclusion Criteria:

  1. Prior history of allergy/adverse reaction to Rasburicase
  2. History of any organ transplant
  3. Preoperative intra-aortic balloon pump (IABP)
  4. Known glucose 6-phosphate dehydrogenase (G6PD) deficiency
  5. Current use of natriuretic peptides

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00756964

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Principal Investigator: A. Ahsan Ejaz, MD University of Florida

Responsible Party: University of Florida Identifier: NCT00756964     History of Changes
Other Study ID Numbers: WIRB 20081132
First Posted: September 22, 2008    Key Record Dates
Results First Posted: September 3, 2012
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by University of Florida:
cardiac surgery

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pathologic Processes
Uric Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Gout Suppressants
Antirheumatic Agents