Clinical trial NCT00756964: Lowering Serum Uric Acid to Prevent Acute Kidney Injury
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperuricemia
Keywords: cardiac surgery
hyperuricemia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-09-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Patients With Acute Kidney Injury (AKI).
timeFrame: Within 48 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: A. Ahsan Ejaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.2215/CJN.00350106. Epub 2006 Dec 6.