search
Back to results

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

Primary Purpose

Contrast Induced Kidney Injury.

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
sodium bicarbonate
Sponsored by
MD Scientific
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Kidney Injury. focused on measuring chronic kidney disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osceola Regional Medical Center
  • Northside Hospital
  • Redmond Regional Medical Center
  • St. Johns Hospital
  • Beth Israel Deaconess Medical Center
  • St Luke's Health System
  • Hackensack University Medical Center
  • Mt Sinai School of Medcine
  • Stony Brook University Medical Center
  • The Christ Hospital
  • St Luke's Heart and Vascular Center
  • Geisinger Medical Center
  • Rhode Island Hospital
  • The Miriam Hospital (Lifespan)
  • Centennial Medical Center
  • Baylor Heart and Vascular Hospital
  • Fletcher Allen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Saline infusion

Sodium Bicarbonate

Arm Description

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.

Infusion of sodium bicarbonate will be given prior to,during and after the contrast agent for a total of 6 to 10 hours

Outcomes

Primary Outcome Measures

Death or renal replacement therapy or sustained kidney injury
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.
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.

Full Information

First Posted
June 26, 2009
Last Updated
August 22, 2012
Sponsor
MD Scientific
search

1. Study Identification

Unique Protocol Identification Number
NCT00930436
Brief Title
Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease
Acronym
BOSS
Official Title
Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MD Scientific

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Kidney Injury.
Keywords
chronic kidney disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
391 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline infusion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sodium Bicarbonate
Arm Type
Experimental
Arm Description
Infusion of sodium bicarbonate will be given prior to,during and after the contrast agent for a total of 6 to 10 hours
Intervention Type
Drug
Intervention Name(s)
sodium bicarbonate
Intervention Description
Serum creatinine will be measured on Days 3,7, 30, 90, and 180
Primary Outcome Measure Information:
Title
Death or renal replacement therapy or sustained kidney injury
Description
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.
Time Frame
Over six months following treatment
Secondary Outcome Measure Information:
Title
A comparison between the treatments for length of hospital stay, post contrast.
Time Frame
Over six months after the treatment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Osceola Regional Medical Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Northside Hospital
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Redmond Regional Medical Center
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
St. Johns Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
St Luke's Health System
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Mt Sinai School of Medcine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
St Luke's Heart and Vascular Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital (Lifespan)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75227
Country
United States
Facility Name
Fletcher Allen Hospital
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs