Rasburicase to Prevent Acute Kidney Injury Following Cardiac Surgery - Full Text View

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00756964

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 II

MedlinePlus related topics: Heart Surgery Surgery

Drug Information available for: Rasburicase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Rasburicase on Acute Kidney Injury, Kidney Function, the Incidence of Renal Replacement Therapy and All-Cause Mortality Following Cardiac Surgery.

Further study details as provided by University of Florida:

Primary Outcome Measures:

the incidence of acute kidney injury (AKI), 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. [ Time Frame: within 48 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

postoperative change in GFR the incidence of dialysis and/or all-cause mortality through day-30 the length of hospital stay the length of ICU stay (ICU-LOS) Urine output [ Time Frame: 24 hours to entire length of hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Study Drug: Active Comparator	Drug: Rasburicase Rasburicase (7.5mg in 50ml of NS over 30 minutes) or identical placebo will be administered as an intravenous infusion preoperatively.
Control: Placebo Comparator	Drug: Placebo The intravenous bags containing rasburicase and placebo drug will be color-coded to appear identical. These will be provided free of cost to the patients.

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 CV 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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756964

Contacts

Contact: A. Ahsan Ejaz, MD	352-273-5328	ejazaa@medicine.ufl.edu
Contact: Thomas M Beaver, MD	352-273-5503	beavetm@surgery.ufl.edu

Locations

United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Contact: A. Ahsan Ejaz, MD 352-273-5328 ejazaa@medicine.ufl.edu
Contact: Thomas M Beaver, MD 352-273-5503 beavetm@surgery.ifl.edu
Principal Investigator: Thomas M Beaver, MD
Sub-Investigator: Richard J Johnson, MD
Sub-Investigator: Tomas M Martin, MD
Sub-Investigator: Puneet Sood, MD
Sub-Investigator: Charles T Klodell, MD
Sub-Investigator: Mohamed Shafiu, MD
Sub-Investigator: Philip J Hess, MD
Sub-Investigator: Vijay Lingegowda, MD
Sub-Investigator: Maria Rojas, MD
Sub-Investigator: Alejandro Paya, MD
Sub-Investigator: Bhagwan Dass, MD
Sub-Investigator: Gurgit S Dhatt, MD
Sub-Investigator: Chirag Faldu, MD
Sub-Investigator: Al-paradis Dana, MD

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 ( A. Ahsan Ejaz, M.D. )
Study ID Numbers:	WIRB 20081132
Study First Received:	September 19, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00756964
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Florida:

cardiac surgery
hyperuricemia

Study placed in the following topic categories:

Uric Acid
Hyperuricemia
Rasburicase

Additional relevant MeSH terms:

Pathologic Processes
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009