Trial Outcomes & Findings for Lowering Serum Uric Acid to Prevent Acute Kidney Injury (NCT NCT00756964)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

Within 48 hours postoperatively

Results posted on

2012-09-03

Participant Flow

Patients were recruited from the Cardiovascular Surgery clinics. Written consents were obtained from all patients.

A large number of patients were screened to achieve the final participant numbers.

Participant milestones

Participant milestones
Measure	Rasburicase Group The drug rasburicase was used in this group.	Placebo Group This group received an identical placebo of rasburicase.
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lowering Serum Uric Acid to Prevent Acute Kidney Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rasburicase Group n=13 Participants The drug rasburicase was used in this group.	Placebo Group n=13 Participants This group received an identical placebo of rasburicase.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 48 hours postoperatively

Population: As no similar study has been performed, a power analysis could not be performed. As such, we decided to do a pilot study with 26 subjects and to set criteria to maximize the likelihood of seeing an effect.

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.

Outcome measures

Outcome measures
Measure	Rasburicase Group n=13 Participants The patients received the drug rasburicase 7.5mg in 50mL of normal saline over 30 minutes period	Placebo Group n=13 Participants The patients which received a placebo identical to rasburicase.
Number of Patients With Acute Kidney Injury (AKI).	13 Participants	13 Participants

Adverse Events

Rasburicase Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

A. Ahsan Ejaz, M.D.

University of Florida

Phone: 3522735328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place