Study of Early Enteral Dextrose in Sepsis

NCT03454087 | Completed DMC

• 2 other identifiers: PRO170105325K23GM122069
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

enteral nutrition; inflammation; incretin hormones; microbiome

Outcome Measures

Primary Outcomes (1)

• Plasma IL-6

  Pro-inflammatory cytokine

  24 hours after start of infusion

Secondary Outcomes (5)

• Additional pro-inflammatory cytokines

  24 hours after start of infusion

• Incretin hormone levels

  24 hours after start of infusion

• Microbiome composition

  24 hours after start of infusion

• Glycemic control

  First 24 hours

• Mortality

  30 days

Study Arms (2)

Enteral Dextrose Infusion

EXPERIMENTAL

Critically-ill participants with sepsis enrolled in the interventional arm will receive a 24-hour infusion of dextrose solution by the enteral route to be initiated via an existing nasogastric or orogastric tube within the first 48 hours of meeting sepsis criteria.

Other: Enteral Dextrose Infusion

Placebo

PLACEBO COMPARATOR

Critically-ill participants with sepsis in the placebo arm will receive a 24-hour enteral free water infusion via an existing orogastric or nasogastric tube within 48 hours of meeting sepsis criteria.

Other: Free Water Infusion

Interventions

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.

Enteral Dextrose Infusion

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15237, United States

Location

Related Publications (2)

• Shah FA, Kitsios GD, Yende S, Dunlap DG, Scholl D, Chuan B, Al-Yousif N, Zhang Y, Nouraie SM, Morris A, Huang DT, O'Donnell CP, McVerry BJ. A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis. Crit Care Explor. 2021 Oct 8;3(10):e550. doi: 10.1097/CCE.0000000000000550. eCollection 2021 Oct.

  PMID: 34651137 DERIVED

• Shah FA, Mahmud H, Gallego-Martin T, Jurczak MJ, O'Donnell CP, McVerry BJ. Therapeutic Effects of Endogenous Incretin Hormones and Exogenous Incretin-Based Medications in Sepsis. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5274-5284. doi: 10.1210/jc.2019-00296.

  PMID: 31216011 DERIVED

MeSH Terms

Conditions

Sepsis; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Faraaz A Shah, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Infusion solutions will be prepared by pharmacy services at the local institution but participants, investigators, care providers, and outcomes assessors will be blinded to group allocation until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized in a blinded 1:1 fashion to receive either a low level enteral infusion of dextrose solution (intervention group) or an enteral infusion of free water (placebo group)

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 5, 2018
• Study Start: June 4, 2018
• Primary Completion: March 2, 2020
• Study Completion: April 1, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)