Study of Early Enteral Dextrose in Sepsis

Completed · Not applicable · Has a placebo group

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT03454087

Run by

University of Pittsburgh

People needed

58

Starts

2018-06-04

Expected to finish

2020-04-01

Last updated by the study team

2020-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Less than 48 hours since meeting criteria for sepsis.
• Expected to stay at least 24 hours in the ICU.

You may not qualify if…

• Pre-existing continuous enteral tube feed use prior to study entry.
• Diabetic ketoacidosis or diabetic hyperosmolar hyperglycemic syndrome.
• Previously enrolled in this study within the same hospital admission.
• ICU physician request to exclude patient based on clinical assessment.

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.