Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00930436
Recruitment Status : Terminated
First Posted : June 30, 2009
Last Update Posted : August 23, 2012
Sponsor:
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

Layout table for study information
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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00930436


Locations
Show Show 17 study locations
Sponsors and Collaborators
MD Scientific

Layout table for additonal information
Responsible Party: MD Scientific
ClinicalTrials.gov Identifier: NCT00930436    
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:
Layout table for MeSH terms
Kidney Diseases
Wounds and Injuries
Urologic Diseases