United States Coronary Artery Bypass Surgery (CABG) Diabetes Project (USCDP) Pilot Study (USCDP)
Primary Purpose
Diabetes, Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strict Glycemic Control for one year post-op CABG
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Diabetes, CABG
Eligibility Criteria
Inclusion Criteria:
- Patients 18 - 80 years old
- Pre-op diagnosis of diabetes
- Scheduled for elective or urgent CABG surgery
- Able to sign informed consent for research study
Exclusion Criteria:
- Patients less than 18 years old or greater than 80 years old
- Emergent or salvage CABG surgery
- Other surgical intervention planned in same setting ( Valve surgery, TMR, MAZE...)
Sites / Locations
- Providence St. Vincent Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
strict glucose control (study arm)
standard insulin treatment (control arm)
Outcomes
Primary Outcome Measures
The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year.
Secondary Outcome Measures
Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.
Full Information
NCT ID
NCT00646438
First Posted
March 25, 2008
Last Updated
February 3, 2009
Sponsor
Providence Heart & Vascular Institute
Collaborators
Sanofi, LifeScan
1. Study Identification
Unique Protocol Identification Number
NCT00646438
Brief Title
United States Coronary Artery Bypass Surgery (CABG) Diabetes Project (USCDP) Pilot Study
Acronym
USCDP
Official Title
United States CABG Diabetes Project (USCDP) Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Providence Heart & Vascular Institute
Collaborators
Sanofi, LifeScan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Standard care for patients with diabetes having CABG surgery at Providence St. Vincent Medical Center includes strict control of blood sugar (glucose) levels for 3 days after surgery. This is done through frequent monitoring of blood sugar levels and by giving insulin continuously through a needle into a vein (intravenously). This intensive glucose control has resulted in fewer complications such as serious infections and death, and has shortened the length of the hospital stay for patients.
This study treatment is different from standard treatment in that it extends the intensive glucose control beyond the third postoperative day to one full year. Once discharged from the hospital following the CABG procedure, the intense glucose control is done using subcutaneous insulin (a shot under the skin), oral medications, and by measuring blood sugar levels frequently.
The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year. Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.
Detailed Description
Purpose Pilot study to gather information for "United States CABG Diabetes Project" (USCDP) Multi-center Randomized Trial.
For 14 years our research team has successfully implemented an increasingly aggressive series of intravenous insulin protocols that normalize blood glucose levels for 3 postoperative days in patients with diabetes who undergo cardiac surgery. This has resulted in significant reductions in mortality, infection and length of stay (LOS) and has normalized those outcomes to those of the population without diabetes (DM). The current protocol ends on the morning of the 3rd postoperative day.
We believe that a logical expansion of this groundbreaking work is to extend the duration of intensive glycemic control beyond the third postoperative day and into the outpatient period. However it would be impossible to do so with the continued use of CII therapy. Therefore, we propose to employ intensive subcutaneous insulin therapies and oral hypoglycemic agents to affect continued tight glycemic control following discontinuation of CII and continue such therapy beyond hospital discharge for a period of at least one year.
We hypothesize that this will lead to further reductions in major adverse cardiac outcomes in the high-risk diabetes coronary artery bypass grafts (CABG) subgroup. The optimal method to test this hypothesis is with a very large, multi-center clinical trial. However, before embarking on such a resource-consuming endeavor, we intend to test the concepts, methods, implementation strategies, patient acceptability and compliance, proposed biomarkers and clinical outcomes of such a trial with this proposed limited pilot study.
If the information obtained from this pilot study is favorable, we will submit for full funding of the multicenter USCDP clinical trial to the NIDDK and NHLBI divisions of the NIH. In order to test all aspects of the proposed trial, we intend to randomize patients into this pilot study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Coronary Artery Disease
Keywords
Diabetes, CABG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
strict glucose control (study arm)
Arm Title
2
Arm Type
No Intervention
Arm Description
standard insulin treatment (control arm)
Intervention Type
Drug
Intervention Name(s)
Strict Glycemic Control for one year post-op CABG
Other Intervention Name(s)
USCDP, Portlan Protocol
Intervention Description
The CDE and Study Coordinator will also meet with the patient in the hospital to show how the Lifescan One-Touch Ultra II glucometer works and review the study follow-up schedule. Patients will be sent home with the Lifescan One-Touch Ultra II glucometer and a supply of strips.
Post-Discharge Period Patients will meet alternatively with the CDE and study doctor on a specific schedule including every week for the first month, every 2 weeks in the second month, and every month thereafter till the 12th month. During these sessions the BG records will be downloaded from the Lifescan One-Touch Ultra II glucometer and reviewed to see patterns and any areas that could be improved or changed.
For all patients in the study arm, the medications that are being taken and the results of glucose monitoring charts will be reviewed weekly with endocrinologists so that any additional recommendations may be made to improve glucose control.
Primary Outcome Measure Information:
Title
The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.
Time Frame
3 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 - 80 years old
Pre-op diagnosis of diabetes
Scheduled for elective or urgent CABG surgery
Able to sign informed consent for research study
Exclusion Criteria:
Patients less than 18 years old or greater than 80 years old
Emergent or salvage CABG surgery
Other surgical intervention planned in same setting ( Valve surgery, TMR, MAZE...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric M. Johnson, BA/CCRC
Phone
503-216-2075
Email
eric.johnson@providence.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tony Furnary, MD
Phone
503-297-1419
Email
tfurnary@mac.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Furnary, MD
Organizational Affiliation
Providence Heart & Vascular Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric M. Johnson, BA/CCRC
Phone
503-216-2075
Email
eric.johnson@providence.org
First Name & Middle Initial & Last Name & Degree
Tony Furnary, MD
Phone
503-297-1419
Email
tfurnary@mac.com
First Name & Middle Initial & Last Name & Degree
Anthony Furnary, MD
12. IPD Sharing Statement
Learn more about this trial
United States Coronary Artery Bypass Surgery (CABG) Diabetes Project (USCDP) Pilot Study
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