United States Coronary Artery Bypass Surgery (CABG) Diabetes Project (USCDP) Pilot Study (USCDP)
Recruitment status was: Not yet recruiting
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.
Coronary Artery Disease
Drug: Strict Glycemic Control for one year post-op CABG
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||United States CABG Diabetes Project (USCDP) Pilot Study|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 1
strict glucose control (study arm)
Drug: Strict Glycemic Control for one year post-op CABG
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.
No Intervention: 2
standard insulin treatment (control arm)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646438
|United States, Oregon|
|Providence St. Vincent Medical Center|
|Portland, Oregon, United States, 97225|
|Principal Investigator:||Anthony Furnary, MD||Providence Heart & Vascular Institute|