Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study seeks to determine whether varying the dose of insulin and glucose in diabetic patients during coronary bypass surgery will improve outcomes in these patients.
Our previous study has shown that maintaining serum glucose between 120-180mg/dl in the perioperative period during CABG surgery in diabetic patients improves outcomes. The purpose of this trial is: (1) to determine whether outcomes can be improved by altering the content of glucose or insulin in these solutions (2)to determine the effect of these solutions and glycemic control on the inflammatory response of arterial and venous conduits used during surgery, (3) to determine whether the beneficial effects of improved glycemic control can be correlated with changes in the inflammatory response.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B Low dose GIK | Active Comparator | This group will have low doses of glucose and insulin |
|
| C High Dose GIK | Active Comparator | This group will have high doses of insulin and glucose |
|
| A Insulin | Active Comparator | This group will receive only an intravenous insulin infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A IV Insulin drip | Drug | These patients will receive 100units of insulin in 100ml of saline intravenously to keep blood glucose between 120-180mg/dl. |
|
| Measure | Description | Time Frame |
|---|---|---|
| glycemic control, postoperative morbidity, inflammatory markers | 24 hours following surgery | |
| glycemic control | 24 hours following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| free fatty acid levels | 24 hours following surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harold L Lazar MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37526194 | Derived | Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3. | |
| 21865944 | Derived | Lazar HL, McDonnell MM, Chipkin S, Fitzgerald C, Bliss C, Cabral H. Effects of aggressive versus moderate glycemic control on clinical outcomes in diabetic coronary artery bypass graft patients. Ann Surg. 2011 Sep;254(3):458-63; discussion 463-4. doi: 10.1097/SLA.0b013e31822c5d78. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| B Low Dose GIK | Drug | These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl |
|
| C High Dose GIK | Drug | This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl |
|