View clinical trials related to Metabolic Stress Hyperglycemia.
Filter by:The process of surgery is a controlled trauma to the body. Trauma induces changes in metabolic function that have evolved to help the body survive injury. The normal balance among use of sugar, fat, and protein for energy production is thought to change during trauma and surgery. This altered metabolic function may contribute to adverse outcomes from surgical procedures especially in the setting of patients with obesity or Type 2 Diabetes Mellitus. However, very little is known about the specific changes in metabolism that occur during surgical procedures. The main objective of this project is to describe the metabolic changes that occur during a typical surgical procedure in detail. In order to measure the alterations in the balanced use of sugar, fat, and protein during surgery we will collect blood samples from patients before, during, and after spinal surgical procedures. Subjects will be enrolled in the pre-operative hold area, give informed consent, and have a dedicated peripheral IV catheter placed. We will recruit patients who are normal weight without diabetes, obese without diabetes, and obese with diabetes. The first specific aim is to characterize the metabolic changes in sugar, fat, and protein balance during surgery in metabolically normal subjects. The second specific aim to examine if there are differences in these changes in subjects who are obese or have diabetes. The final specific aim is to measure the changes in metabolism at high resolution using a method called metabolomics, which is analogous to genome profiling. This method measures hundreds of compounds produced in different amounts as metabolic balance changes. The major impacts that may be derived from these data range from a more thorough understanding of metabolism under trauma to identification of new markers for risk stratification and intervention to improve clinical outcomes. These data will help build the foundation for new approaches to understanding the physiological and metabolic responses to stress and trauma.
After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate treatment cohort will then be consecutively enrolled, followed by the tight glycemic control cohort. After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory evaluations will be determined. Subjects enrolled in the standard of care cohort will be treated according to the institution's protocol for measuring glucose and managing insulin. These subjects will be monitored on a GlucoClear System but they will not be managed based on the values or trends of the GlucoClear system. Subjects enrolled in the treatment cohorts will be monitored and managed with a special version of the GlucoClear continuous monitoring system. This system contains the GlucoClear Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to manage patient glucose within pre-specified target levels. These recommendations are presented on screen for a clinical professional to approve or override. Subjects in the moderate treatment cohort will have their glucose managed in the range of 120 - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in the range of 80 - 120 mg/dl. After discharge from the ICU, subjects will followed for adverse events and mortality at 30 days, either by telephone contact or office visit.