Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 10/28/2018 |
| Start Date: | July 2007 |
| End Date: | April 2015 |
The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery
Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will
be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood
glucose levels intra-operatively. Group B will be administered insulin at the standard of
care levels established by the participating institution. Patients will be followed at 10
days, 15 days and one year post-operatively.
be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood
glucose levels intra-operatively. Group B will be administered insulin at the standard of
care levels established by the participating institution. Patients will be followed at 10
days, 15 days and one year post-operatively.
Using a randomized, controlled design, we propose to test the primary hypothesis that
normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces
the risk of a composite outcome (one or more) of 30-day postoperative mortality and serious
postoperative cardiac, renal, neurologic, and infectious postoperative complications in
patients undergoing cardiac surgery.
Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of
stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission,
all-cause and cardiac one-year mortality.
normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces
the risk of a composite outcome (one or more) of 30-day postoperative mortality and serious
postoperative cardiac, renal, neurologic, and infectious postoperative complications in
patients undergoing cardiac surgery.
Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of
stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission,
all-cause and cardiac one-year mortality.
Inclusion Criteria:
- Age 18-90 years old
- Scheduled for cardiac surgery requiring cardiopulmonary bypass
Exclusion Criteria:
- Off-pump surgical procedures
- Anticipated deep hypothermic circulatory arrest
- In available, baseline cardiac troponin I (>0.5 ng/L) or troponin T (> 0.1 ng/mL)
levels (at RVH or CC, respectively)
- Any contraindications to the proposed interventions
- Active infection, including patients with endocarditis or infected pacemaker leads.
- Any infection requiring long- term antibiotics ( > 14 days)
- kidney disease requiring renal replacement therapy
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