Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease
BOSS
1 other identifier
interventional
391
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2010
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedAugust 23, 2012
February 1, 2012
2.6 years
June 26, 2009
August 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Over six months following treatment
Secondary Outcomes (2)
A comparison between the treatments for length of hospital stay, post contrast.
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.
six months after receiving IP
Study Arms (2)
Saline infusion
ACTIVE COMPARATORSaline 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
EXPERIMENTALInfusion of sodium bicarbonate will be given prior to,during and after the contrast agent for a total of 6 to 10 hours
Interventions
Serum creatinine will be measured on Days 3,7, 30, 90, and 180
Eligibility Criteria
You may qualify if:
- Candidate for angiography
- Stage 3B, 4 or 5 Chronic kidney disease (i.e. eGFR \<=44)
- Either sex over 18 years of age
You may not qualify if:
- Pregnant or breast feeding
- On any kidney replacement list
- Gastric tube in place or gastric drainage
- Uncorrected hypoglycemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MD Scientificlead
Study Sites (17)
Osceola Regional Medical Center
Kissimmee, Florida, 34741, United States
Northside Hospital
St. Petersburg, Florida, 33709, United States
Redmond Regional Medical Center
Rome, Georgia, 30165, United States
St. Johns Hospital
Springfield, Illinois, 62701, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
St Luke's Health System
Kansas City, Missouri, 64111, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Mt Sinai School of Medcine
New York, New York, 10029, 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, 18015, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital (Lifespan)
Providence, Rhode Island, 02906, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75227, United States
Fletcher Allen Hospital
Burlington, Vermont, 05401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2009
First Posted
June 30, 2009
Study Start
January 1, 2010
Primary Completion
August 1, 2012
Study Completion
September 1, 2012
Last Updated
August 23, 2012
Record last verified: 2012-02