NCT03454087: SEEDS

Study of Early Enteral Dextrose in Sepsis

Completed NA Last updated 7 April 2020

What this trial tests

NA trial testing Enteral Dextrose Infusion in Sepsis in 58 participants. Completed in 1 April 2020.

Timeline

4 June 2018

Primary endpoint
2 March 2020

1 April 2020

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	58
Start date	4 June 2018
Primary completion	2 March 2020
Estimated completion	1 April 2020
Sites	1 location across United States

Drugs / interventions tested

• Enteral Dextrose Infusion
• Free Water Infusion

Conditions studied

• Sepsis — all drugs for Sepsis →

Sponsor

University of Pittsburgh

Who can join

18 and older, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic Effects of Endogenous Incretin Hormones and Exogenous Incretin-Based Medications in Sepsis.
   Shah FA, Mahmud H, Gallego-Martin T, Jurczak MJ, et al · · 2019 · cited 21× · PMID 31216011 · DOI 10.1210/jc.2019-00296
2. Rationale for and Design of the Study of Early Enteral Dextrose in Sepsis: A Pilot Placebo-Controlled Randomized Clinical Trial.
   Shah FA, Kitsios GD, Zhang Y, Morris A, et al · · 2020 · cited 4× · PMID 31148210 · DOI 10.1002/jpen.1608
3. A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis.
   Shah FA, Kitsios GD, Yende S, Dunlap DG, et al · · 2021 · cited 1× · PMID 34651137 · DOI 10.1097/cce.0000000000000550