Study of Early Enteral Dextrose in Sepsis
Study of Early Enteral Dextrose in Sepsis
This study is a prospective single-center randomized double-blinded placebo-controlled
 clinical trial testing the effects of early enteral dextrose as a therapeutic agent in
 critically ill patients with sepsis. Primary outcomes are differences in circulating plasma
 levels of the pro-inflammatory cytokine IL-6 to be tested 24 hours after the start of enteral
 infusion. Secondary outcomes include differences in circulating incretin hormone levels,
 differences in other pro-inflammatory cytokines including IL-1β and TNF-α, changes in
 intestinal microbial composition and function after intervention, glycemic control and
 variability as assessed by capillary blood glucose measurements and exogenous insulin dosing
 during the intervention period, and clinical outcomes including intensive care unit (ICU) and
 hospital stay and in-hospital mortality.
The central objective of this research project is to determine how early caloric support
 impacts inflammatory and metabolic outcomes in the acute phase of sepsis. Preliminary data
 from our mouse models suggest that provision of dextrose via an intravenous route, even at
 low levels early in the course of sepsis, markedly impairs glucose tolerance and decreases
 insulin sensitivity and insulin secretion. In contrast, provision of low-level dextrose by
 the enteral route at identical levels during the early phase of sepsis is associated with
 decreased inflammation, increased secretion of beneficial intestine-derived incretin
 hormones, and significant improvements in glucose metabolism. The goals of this clinical
 study are to translate findings on the beneficial role of early enteral dextrose in a pilot
 interventional trial in critically-ill patients with sepsis. This clinical trial will provide
 further insight into the optimal timing and route of early caloric support in the care of
 septic patients-an area of clinical practice that will benefit from further studies in
 fundamental biology and clear guidelines for physicians.
Inclusion Criteria:

 1. New presentation of sepsis characterized by a confirmed or suspected infection, with
 an acute increase from baseline in a modified Sepsis-Related Organ Failure Assessment
 (SOFA) score of greater than or equal to 2 points. If baseline values are unknown,
 baseline SOFA score of 0 will be assumed.

 2. Available enteral access defined by: (1) an existing nasogastric or orogastric tube,
 (2) plans to place a nasogastric or orogastric tube, or (3) an existing percutaneous
 endoscopic gastrostomy (PEG) tube.

 3. Less than 48 hours since meeting criteria for sepsis.

 4. Expected to stay at least 24 hours in the ICU.

 Exclusion Criteria:

 1. Pre-existing continuous enteral tube feed use prior to study entry.

 2. Diabetic ketoacidosis or diabetic hyperosmolar hyperglycemic syndrome.

 3. Previously enrolled in this study within the same hospital admission.

 4. ICU physician request to exclude patient based on clinical assessment.