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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
391
Serum creatinine will be measured on Days 3,7, 30, 90, and 180
Osceola Regional Medical Center
Kissimmee, Florida, United States
Northside Hospital
St. Petersburg, Florida, United States
Redmond Regional Medical Center
Rome, Georgia, United States
St. Johns Hospital
Springfield, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
St Luke's Health System
Kansas City, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mt Sinai School of Medcine
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
...and 7 more locations
Death or renal replacement therapy or sustained kidney injury
Sustained kidney injury is two sequential 20% reduction of eGFR from baseline as calculated from change in sertum creatinine at least three weeks after receiving IP.
Time frame: Over six months following treatment
A comparison between the treatments for length of hospital stay, post contrast.
Time frame: Over six months after the treatment
A comparison between the treatments of the time to renal replacement therapy (any type) or death (whichever occurs first) over the 6-month observation period.
Time frame: six months after receiving IP
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