MedDataX Logo

Lowering Serum Uric Acid to Prevent Acute Kidney Injury

NCT ID: NCT00756964

Last Updated: 2012-09-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperuricemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

cardiac surgery hyperuricemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rasburicase

patients receiving rasburicase to lower serum uric acid

Group Type ACTIVE_COMPARATOR

Rasburicase

Intervention Type DRUG

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.

Placebo

patients will receive a placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

urate oxidase enzyme inactive ingredient

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

A. Ahsan Ejaz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Florida

Gainesville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17699382 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WIRB 20081132

Identifier Type: -

Identifier Source: org_study_id