The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Surgery induces a stress effect on the body partially through a catabolic energy state. In turn, glucose levels may rise to levels which have been associated with major morbidity (Golden, 1999) and mortality (Ouattara, 2005). An increasing body of evidence suggests that intensive insulin therapy for tight control of blood glucose levels in certain surgical and critical care patient populations may improve mortality and selected morbidity outcomes when compared to those patients receiving conventional insulin therapy and blood glucose management. More specifically, poor intra-operative blood glucose control is associated with worse outcome after cardiac surgery. Intensive insulin therapy with tight blood glucose control in surgical patients while in the ICU may reduce morbidity and mortality. Such outcome improvements would clearly provide benefits to patients, providers and payers. To date, there is scant research examining whether intensive insulin therapy for tight control of blood glucose in the perioperative period can alter outcomes for the non cardiac surgery population. The purpose of this study is to determine whether intensive insulin therapy for tight control of blood glucose in the perioperative period in non cardiac major surgery patients is associated with altered morbidity and mortality rates.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Patients scheduled for non emergent surgery under either general or regional anesthesia deemed to have moderate to high physiologic stress

• Male and female subjects over the age of 18 with or without a diagnosis of diabetes mellitus

• Patients must be able to provide informed consent

Exclusion Criteria:

• Cognitively impaired

• Non-English or Spanish speaking with no relative present who is fluent in reading and comprehending English or Spanish.

• Female patients of child bearing age who have a positive pregnancy test on admission.