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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 26, 2009
Last Updated Date	August 22, 2012
Start Date ^ICMJE	January 2010
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 23, 2012)	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.
Original Primary Outcome Measures ^ICMJE (submitted: June 29, 2009)	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 ]
Change History	Complete list of historical versions of study NCT00930436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 23, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 29, 2009)	Renal replacement therapy (eg, renal dialysis) [ Time Frame: Over six months after the treatment ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease
Official Title ^ICMJE	Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Contrast Induced Kidney Injury.
Intervention ^ICMJE	Drug: sodium bicarbonate Serum creatinine will be measured on Days 3,7, 30, 90, and 180
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	391
Estimated Completion Date	September 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00930436
Other Study ID Numbers ^ICMJE	MDS001
Has Data Monitoring Committee	Yes
Responsible Party	MD Scientific
Study Sponsor ^ICMJE	MD Scientific
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	MD Scientific
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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