Study of Early Enteral Dextrose in Sepsis

Sepsis Clinical Trial

— SEEDS  

Official title:

Study of Early Enteral Dextrose in Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454087
• Other study ID #: PRO17010532
• Secondary ID: 5K23GM122069
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 1, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• Enteral Dextrose Infusion
A standard solution of 50% Dextrose (0.85 kcal/mL) will be infused via enteral route at a rate of 10 mL per hour for a duration of 24 hours.
• Free Water Infusion
An infusion of free water will be initiated via enteral route at a rate of 10 mL per hour for a duration of 24 hours.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma IL-6	Pro-inflammatory cytokine	24 hours after start of infusion
Secondary	Additional pro-inflammatory cytokines	Circulating levels of other pro-inflammatory cytokines including IL-1 beta and TNF-alpha (each to be determined in pg/mL)	24 hours after start of infusion
Secondary	Incretin hormone levels	Circulating levels of the intestine-derived hormones GIP and GLP-1 (each to be determined in pg/mL)	24 hours after start of infusion
Secondary	Microbiome composition	Analysis of the composition and distribution of microorganisms of the gut and respiratory microbiome measured after intervention from tracheal aspirates and rectal swabs	24 hours after start of infusion
Secondary	Glycemic control	Capillary blood glucose measurements during infusion period	First 24 hours
Secondary	Mortality	In-hospital mortality at 30 days	30 days