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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00756964
First received: September 19, 2008
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Hyperuricemia
 Drug: Rasburicase
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Number of Patients With Acute Kidney Injury (AKI). [ Time Frame: Within 48 hours postoperatively ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: October 2008
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756964

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:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00756964     History of Changes
Other Study ID Numbers: WIRB 20081132
Study First Received: September 19, 2008
Results First Received: November 23, 2011
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013