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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

June 26, 2009
August 22, 2012
January 2010
August 2012   (final data collection date for primary outcome measure)
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.
  • Primary: Serum creatinine [ Time Frame: Over six months following treatment ] [ Designated as safety issue: Yes ]
  • Renal replacement therapy (e.g., renal dialysis or other dialysis) [ Time Frame: Over a six month period following treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00930436 on ClinicalTrials.gov Archive Site
  • 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 ]
Renal replacement therapy (eg, renal dialysis) [ Time Frame: Over six months after the treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease
Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Contrast Induced Kidney Injury.
Drug: sodium bicarbonate
Serum creatinine will be measured on Days 3,7, 30, 90, and 180
  • 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.
    Intervention: Drug: sodium bicarbonate
  • 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
    Intervention: Drug: sodium bicarbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
391
September 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00930436
MDS001
Yes
MD Scientific
MD Scientific
Not Provided
Not Provided
MD Scientific
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP