Who is sponsoring NCT00484354?

NCT00484354 is sponsored by Wake Forest University Health Sciences.

What condition does NCT00484354 study?

NCT00484354 studies Kidney Failure, Acute, Renal Replacement Therapy.

What drugs are being tested in NCT00484354?

Interventions: Sodium bicarbonate, Normal saline, Bicarbonate, Placebo.

What is the status of NCT00484354?

NCT00484354 is currently COMPLETED.

Last reviewed 2018-09-20 · How we verify

Reduction of Acute Renal Failure Associated With Cardiovascular Surgery: A Randomized Study Comparing Sodium Bicarbonate to Normal Saline

NCT00484354 Phase 2 COMPLETED Results posted

The purpose of this study is to determine if the incidence of acute renal failure (ARF) in high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal saline. The volume of fluid given in each arm of the study is equal. All other interventions in those patients will be according to standard cardiothoracic anesthesia protocol at our institution.

Details

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2
Status	COMPLETED
Enrolment	123
Start date	2006-05
Completion	2013-12

Conditions

Kidney Failure, Acute
Renal Replacement Therapy

Interventions

Sodium bicarbonate
Normal saline
Bicarbonate
Placebo

Primary outcomes

Number of Participants Who Developed Acute Kidney Injury Within 72 Hours — 72 hours post-operative
Number (percentage) of patients who developed acute kidney injury within 72 hours, defined by an increase in serum creatinine level of 0.3 mg/dl from baseline

Countries

United States