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

• ClinicalTrials.gov Identifier: NCT00756964
• Recruitment Status: Completed
• First Posted: September 22, 2008
• Results First Posted: September 3, 2012
• Last Update Posted: September 3, 2012
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Florida

University of Florida

Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: A. Ahsan Ejaz, MD; University of Florida

More Information

Publications:

Ejaz AA, Mu W, Kang DH, Roncal C, Sautin YY, Henderson G, Tabah-Fisch I, Keller B, Beaver TM, Nakagawa T, Johnson RJ. Could uric acid have a role in acute renal failure? Clin J Am Soc Nephrol. 2007 Jan;2(1):16-21. Epub 2006 Dec 6. Review.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT00756964
• Other Study ID Numbers: WIRB 20081132
• First Posted: September 22, 2008
• Results First Posted: September 3, 2012
• Last Update Posted: September 3, 2012
• Last Verified: August 2012

Keywords provided by University of Florida:

cardiac surgery; hyperuricemia

Additional relevant MeSH terms:

Acute Kidney Injury; Hyperuricemia; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Pathologic Processes; Rasburicase; Gout Suppressants; Antirheumatic Agents