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

August 22, 2012 updated by: MD Scientific

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

391

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Over six months following treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
A comparison between the treatments for length of hospital stay, post contrast.
Time Frame: Over six months after the treatment
Over six months after the treatment
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
six months after receiving IP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MD Scientific

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

June 26, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (Estimate)

June 30, 2009

Study Record Updates

Last Update Posted (Estimate)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contrast Induced Kidney Injury.

Clinical Trials on sodium bicarbonate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe