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Tight Intra-Operative Glucose Control Using Continuous Insulin Infusion During Coronary Artery Bypass Surgery: Randomized Controlled Trial
Blood glucose levels increase in response to stress, infection or other conditions faced by patients in the hospital. This occurs commonly among patients with known diabetes, but also among non-diabetic hospitalized patients. Tight glucose control, the maintenance of blood glucose levels within normal limits (80-120 mg/dl), has been shown to improve patient outcomes in the hospital in several settings, mainly among critically ill patients hospitalized in intensive care units. We plan to assess the importance of tight glucose control during open-heart surgery. The prevalence of hyperglycemia (elevated blood glucose) during this operation is high. Hyperglycemia may be associated with increased vulnerability to surgical site infections, neurological damage, cardiac and renal injury. Conversely, tight glucose control may be associated with hypoglycemia (pathologically low glucose levels) that may results in neurological injury. We hypothesize that tight glucose control will improve patient outcomes following surgery.
Details
| Lead sponsor | Rabin Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 1400 |
| Start date | 2007-02 |
| Completion | 2009-08 |
Conditions
- Coronary Artery Bypass
Interventions
- Intraoperative continuous insulin infusion
- Control
Primary outcomes
- 30-day all-cause mortality. — 30-day
- Deep or organ/ space (mediastinitis) surgical site infections. — 90 days
- Acute renal failure during post-operative ICU stay, defined as: doubling of serum creatinine from baseline; or >50% reduction from baseline glomerular filtration rate; or need for renal replacement therapy. — 30 days
- Perioperative cerebrovascular event defined as any new, temporary or permanent, focal or global neurological deficit. — 30 days
Countries
Israel