United States Coronary Artery Bypass Surgery (CABG) Diabetes Project (USCDP) Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | March 2009 |
| End Date: | December 2012 |
| Contact: | Eric M. Johnson, BA/CCRC |
| Email: | eric.johnson@providence.org |
| Phone: | 503-216-2075 |
United States CABG Diabetes Project (USCDP) Pilot Study
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.
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.
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.
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.
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...)
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