Study of Early Enteral Dextrose in Sepsis
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | June 4, 2018 |
| End Date: | June 30, 2022 |
| Contact: | Faraaz A Shah, MD |
| Email: | shahfa@upmc.edu |
| Phone: | 412-692-2210 |
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.
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.
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.
We found this trial at
1
site
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Faraaz A Shah, MD
Phone: 412-692-2210
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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