Phase 3
N=305
Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01361594 ↗Enrolled (actual)
305
Serious AEs
46.7%
Results posted
Dec 2014
Primary outcome: Primary: Number of Subjects That Were Diagnosed for Peri-operative Complications — 58; 70 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Regular insulin (intensive treatment) (Other); Regular Insulin (conventional treatment) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects That Were Diagnosed for Peri-operative Complications |
58; 70 | — |
| PRIMARY Hospital Mortality |
5; 2 | — |
| SECONDARY Glycemic Control |
— | — |
| SECONDARY Major Cardiovascular Events |
— | — |
| SECONDARY Acute Renal Failure |
— | — |
| SECONDARY Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg. |
— | — |
| SECONDARY ICU and Hospital Length of Stay, and ICU Readmissions |
— | — |
| SECONDARY Surgical Wound Infection |
— | — |
| SECONDARY Pneumonia (CDC Criteria) |
— | — |
| SECONDARY Cerebrovascular Events |
— | — |
| SECONDARY Duration of Ventilatory Support and ICU Readmission |
— | — |
| SECONDARY Thirty Day Mortality |
— | — |
| SECONDARY Number of Hospital Readmissions and Emergency Room Visits |
— | — |
| SECONDARY Incidence of Organ Failures Assessed by the Daily SOFA Score |
— | — |
| SECONDARY Measures of Inflammation |
— | — |
| SECONDARY Major Cardiovascular Events |
— | — |
| SECONDARY Surgical Wound Infection |
— | — |
| SECONDARY Pneumonia (CDC Criteria) |
— | — |
| SECONDARY Cerebrovascular Events |
— | — |
Summary
High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are associated with increased risk of hospital complications. Blood sugar control with intravenous insulin may prevent such hospital complications. Many patients undergoing cardiac bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before or after surgery). It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. Accordingly, this research study aims to determine optimal blood glucose levels during the in patients undergoing cardiac bypass surgery. Patients will be divided in two groups. The intensive insulin group will be maintained at blood glucose between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180 mg/dl. The insulins to be used in this trial (lantus, aspart and regular insulin) are approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration). A total of 326 patients with high blood glucose after cardiac bypass surgery will be recruited in this study. Patients will be recruited at Emory University Hospital, Emory Midtown Hospital and Grady Memorial Hospital.
Eligibility Criteria
Inclusion Criteria
- Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.
- Post surgical hyperglycemia (BG > 140 mg/dl).
- Patients with and without a history of type 2 diabetes
Exclusion Criteria
- Patients requiring combination CABG with additional procedures such aorta replacement.
- Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR < 30 ml/min) or clinically significant hepatic failure.
- Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
- Patients or next-to-kin with mental condition rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study.
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
Data sourced from ClinicalTrials.gov (NCT01361594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.