Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease
NCT ID: NCT00930436
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
391 participants
INTERVENTIONAL
2010-01-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Saline infusion
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
Serum creatinine will be measured on Days 3,7, 30, 90, and 180
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
sodium bicarbonate
Serum creatinine will be measured on Days 3,7, 30, 90, and 180
Interventions
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sodium bicarbonate
Serum creatinine will be measured on Days 3,7, 30, 90, and 180
Eligibility Criteria
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Inclusion Criteria
* Stage 3B, 4 or 5 Chronic kidney disease (i.e. eGFR \<=44)
* Either sex over 18 years of age
Exclusion Criteria
* On any kidney replacement list
* Gastric tube in place or gastric drainage
* Uncorrected hypoglycemia
18 Years
ALL
No
Sponsors
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MD Scientific
INDUSTRY
Responsible Party
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Locations
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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
St Luke's Heart and Vascular Center
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, 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
Countries
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Other Identifiers
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MDS001
Identifier Type: -
Identifier Source: org_study_id
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