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Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease (BOSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00930436
Recruitment Status : Terminated
First Posted : June 30, 2009
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Contrast Induced Kidney Injury. Drug: sodium bicarbonate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography
Study Start Date : January 2010
Actual Primary Completion Date : August 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: 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.
Drug: sodium bicarbonate
Serum creatinine will be measured on Days 3,7, 30, 90, and 180

Experimental: 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
Drug: sodium bicarbonate
Serum creatinine will be measured on Days 3,7, 30, 90, and 180

Primary Outcome Measures :
  1. Death or renal replacement therapy or sustained kidney injury [ Time Frame: 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 :
  1. A comparison between the treatments for length of hospital stay, post contrast. [ Time Frame: Over six months after the treatment ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Candidate for angiography
  • Stage 3B, 4 or 5 Chronic kidney disease (i.e. eGFR <=44)
  • Either sex over 18 years of age

Exclusion Criteria:

  • Pregnant or breast feeding
  • On any kidney replacement list
  • Gastric tube in place or gastric drainage
  • Uncorrected hypoglycemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00930436

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United States, Florida
Osceola Regional Medical Center
Kissimmee, Florida, United States, 34741
Northside Hospital
St Petersburg, Florida, United States, 33709
United States, Georgia
Redmond Regional Medical Center
Rome, Georgia, United States, 30165
United States, Illinois
St. Johns Hospital
Springfield, Illinois, United States, 62701
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
United States, Missouri
St Luke's Health System
Kansas City, Missouri, United States, 64111
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Mt Sinai School of Medcine
New York, New York, United States, 10029
Stony Brook University Medical Center
Stony Brook, New York, United States
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States
United States, Pennsylvania
St Luke's Heart and Vascular Center
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
The Miriam Hospital (Lifespan)
Providence, Rhode Island, United States, 02906
United States, Tennessee
Centennial Medical Center
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Heart and Vascular Hospital
Dallas, Texas, United States, 75227
United States, Vermont
Fletcher Allen Hospital
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
MD Scientific

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Responsible Party: MD Scientific Identifier: NCT00930436     History of Changes
Other Study ID Numbers: MDS001
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: February 2012

Keywords provided by MD Scientific:
chronic kidney disease

Additional relevant MeSH terms:
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Wounds and Injuries
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency