Phase 2 N=26 Randomized Quadruple-blind Prevention

Lowering Serum Uric Acid to Prevent Acute Kidney Injury

Hyperuricemia

Bottom Line

View on ClinicalTrials.gov: NCT00756964 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Number of Patients With Acute Kidney Injury (AKI). — 13; 13 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rasburicase (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Acute Kidney Injury (AKI).	13; 13	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00756964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.