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NCT Number: NCT03454087

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15237, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Enteral Dextrose Infusion

Other

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

Other

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.

Primary outcomes

  1. Plasma IL-6

    Time frame: 24 hours after start of infusion

    Pro-inflammatory cytokine

Secondary outcomes

  1. Additional pro-inflammatory cytokines

    Time frame: 24 hours after start of infusion

    Circulating levels of other pro-inflammatory cytokines including IL-1 beta and TNF-alpha (each to be determined in pg/mL)

  2. Incretin hormone levels

    Time frame: 24 hours after start of infusion

    Circulating levels of the intestine-derived hormones GIP and GLP-1 (each to be determined in pg/mL)

  3. Microbiome composition

    Time frame: 24 hours after start of infusion

    Analysis of the composition and distribution of microorganisms of the gut and respiratory microbiome measured after intervention from tracheal aspirates and rectal swabs

  4. Glycemic control

    Time frame: First 24 hours

    Capillary blood glucose measurements during infusion period

  5. Mortality

    Time frame: 30 days

    In-hospital mortality at 30 days

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • National Institutes of Health (NIH)

Registry information

Acronym: SEEDS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2018
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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