Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease
- Registration Number
- NCT00930436
- Lead Sponsor
- MD Scientific
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 391
- Candidate for angiography
- Stage 3B, 4 or 5 Chronic kidney disease (i.e. eGFR <=44)
- Either sex over 18 years of age
- Pregnant or breast feeding
- On any kidney replacement list
- Gastric tube in place or gastric drainage
- Uncorrected hypoglycemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline infusion sodium bicarbonate Saline will be given as an active control agent to compare with sodium bicarbonate. Each bag of solution will be blinded, and given in the same manner. Sodium Bicarbonate sodium bicarbonate Infusion of sodium bicarbonate will be given prior to,during and after the contrast agent for a total of 6 to 10 hours
- Primary Outcome Measures
Name Time Method Death or renal replacement therapy or sustained kidney injury Over six months following treatment 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.
- Secondary Outcome Measures
Name Time Method 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. six months after receiving IP A comparison between the treatments for length of hospital stay, post contrast. Over six months after the treatment
Trial Locations
- Locations (17)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Mt Sinai School of Medcine
🇺🇸New York, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
St. Johns Hospital
🇺🇸Springfield, Illinois, United States
Osceola Regional Medical Center
🇺🇸Kissimmee, Florida, United States
Northside Hospital
🇺🇸St Petersburg, Florida, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Redmond Regional Medical Center
🇺🇸Rome, Georgia, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
St Luke's Health System
🇺🇸Kansas City, Missouri, United States
St Luke's Heart and Vascular Center
🇺🇸Bethlehem, Pennsylvania, United States
The Miriam Hospital (Lifespan)
🇺🇸Providence, Rhode Island, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Fletcher Allen Hospital
🇺🇸Burlington, Vermont, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States