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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
MD Scientific
ClinicalTrials.gov Identifier:
NCT00930436
First received: June 26, 2009
Last updated: August 22, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Contrast Induced Kidney Injury.
Drug: sodium bicarbonate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by MD Scientific:

Primary Outcome Measures:
  • Death or renal replacement therapy or sustained kidney injury [ Time Frame: Over six months following treatment ] [ Designated as safety issue: Yes ]
    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:
  • A comparison between the treatments for length of hospital stay, post contrast. [ Time Frame: Over six months after the treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 391
Study Start Date: January 2010
Estimated Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930436

Locations
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
  More Information

No publications provided

Responsible Party: MD Scientific
ClinicalTrials.gov Identifier: NCT00930436     History of Changes
Other Study ID Numbers: MDS001
Study First Received: June 26, 2009
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by MD Scientific:
chronic kidney disease

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

ClinicalTrials.gov processed this record on November 27, 2014