Boss

Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography

Boss [NCT00930436]

Description: Patients with Stage 3B, 4,or 5 Chronic Kidney Disease who are to undergo an angiography procedure with contrast agent will be asked if they are willing to join the trial. If so they will be screened and randomized to receive either sodium bicarbonate or saline before, during and after the contrast media is given. They will be asked for serum samples 1 to 3 days, 7, 30, 90 and 180 days after the procedure to evaluate whether the sodium bicarbonate has reduced the incidence of contrast induced chronic kidney disease by measuring their serum creatinine, as well as whether they have required renal dialysis or other renal replacement therapy.

Drug: Sodium Bicarbonate; Drug: Placebo

Primary Investigator: Kereiakes

Drug/Device Information
Sodium Bicarbonate versus placebo to reduce contrast injury in chronic kidney disease during angiography.
Receives 5 ml/kg over 1 to 5 hours pre-angiography then 1.5 ml/kg/hour for four hours
MD Scientific, LLC
Major Inclusion and Exclusion
eGFR ≤ 44 (No dialysis)
Known hypocalcemia (if treated can enroll)
Can not be acute kidney failure defined as an increased creatinine of > 0.5 mg/dl over the prior 3 days