NCT00756964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 3, 2012

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

2.7 years

First QC Date

September 19, 2008

Results QC Date

November 23, 2011

Last Update Submit

August 1, 2012

Conditions

Hyperuricemia

Keywords

cardiac surgeryhyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Acute Kidney Injury (AKI).

    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.

    Within 48 hours postoperatively

Study Arms (2)

Rasburicase

ACTIVE COMPARATOR

patients receiving rasburicase to lower serum uric acid

Drug: Rasburicase

Placebo

PLACEBO COMPARATOR

patients will receive a placebo

Drug: Placebo

Interventions

RasburicaseDRUG

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.

Also known as: urate oxidase enzyme
Rasburicase
PlaceboDRUG

Placebo drug (color-coded to appear identical to study drug) administered as an (dosage form) intravenous infusion preoperatively.

Also known as: inactive ingredient
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • 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.

    PMID: 17699382BACKGROUND

MeSH Terms

Conditions

Hyperuricemia

Interventions

rasburicaseExcipients

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical VehiclesPharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Limitations and Caveats

The limitation of the pilot study is that it was not powered to provide definite answers, an inherent limitation attributed to the absence of similar studies.

Results Point of Contact

Title
A. Ahsan Ejaz, M.D.
Organization
University of Florida
ejazaa@medicine.ufl.edu
3522735328

Study Officials

  • A. Ahsan Ejaz, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

October 1, 2008

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

September 3, 2012

Results First Posted

September 3, 2012

Record last verified: 2012-08

Locations

US(1)