Rationale for and Design of the Study of Early Enteral Dextrose in Sepsis: A Pilot Placebo-Controlled Randomized Clinical Trial.
dextrose
enteral nutrients
incretin
inflammation
microbiome
sepsis
Journal
JPEN. Journal of parenteral and enteral nutrition
ISSN: 1941-2444
Titre abrégé: JPEN J Parenter Enteral Nutr
Pays: United States
ID NLM: 7804134
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
04
02
2019
revised:
19
04
2019
accepted:
03
05
2019
pubmed:
31
5
2019
medline:
4
3
2021
entrez:
1
6
2019
Statut:
ppublish
Résumé
Sepsis is characterized by life-threatening organ dysfunction caused by a dysregulated host response to infection and affects over 1 million Americans annually. Loss of glycemic control in sepsis is associated with increased morbidity and mortality, and novel approaches are needed to promote euglycemia and improve outcomes in sepsis. Recent studies from our laboratory demonstrate that early low-level enteral dextrose infusion in septic mice attenuates the systemic inflammatory response and improves glycemic control by inducing intestine-derived incretin hormone secretion. The aim of the Study of Early Enteral Dextrose in Sepsis (SEEDS) is to test the effect of a 24-hour enteral dextrose infusion in critically ill septic patients as a therapeutic agent to decrease systemic inflammation and promote euglycemia. SEEDS is a single-center, double-blind, randomized, controlled trial that will enroll 60 septic patients admitted to the intensive care units at the University of Pittsburgh Medical Center Health System in Pittsburgh. Participants will be randomized 1:1 to receive enteral dextrose (n = 30) or water (placebo, n = 30) infusion for 24 hours. The primary outcome is the circulating interleukin-6 level measured after the 24-hour infusion compared between dextrose and placebo groups. Secondary outcomes include postinfusion circulating insulin, incretin, and other proinflammatory cytokine levels, as well as incidence of hyperglycemia and hypoglycemia during the infusion period. This trial will characterize the effects of early enteral dextrose on endogenous endocrine pathways and the systemic inflammatory response in sepsis. The results of this trial will inform future larger interventional studies of early enteral nutrients in critically ill patients with sepsis.
Sections du résumé
BACKGROUND
Sepsis is characterized by life-threatening organ dysfunction caused by a dysregulated host response to infection and affects over 1 million Americans annually. Loss of glycemic control in sepsis is associated with increased morbidity and mortality, and novel approaches are needed to promote euglycemia and improve outcomes in sepsis. Recent studies from our laboratory demonstrate that early low-level enteral dextrose infusion in septic mice attenuates the systemic inflammatory response and improves glycemic control by inducing intestine-derived incretin hormone secretion.
AIM
The aim of the Study of Early Enteral Dextrose in Sepsis (SEEDS) is to test the effect of a 24-hour enteral dextrose infusion in critically ill septic patients as a therapeutic agent to decrease systemic inflammation and promote euglycemia.
METHODS
SEEDS is a single-center, double-blind, randomized, controlled trial that will enroll 60 septic patients admitted to the intensive care units at the University of Pittsburgh Medical Center Health System in Pittsburgh. Participants will be randomized 1:1 to receive enteral dextrose (n = 30) or water (placebo, n = 30) infusion for 24 hours. The primary outcome is the circulating interleukin-6 level measured after the 24-hour infusion compared between dextrose and placebo groups. Secondary outcomes include postinfusion circulating insulin, incretin, and other proinflammatory cytokine levels, as well as incidence of hyperglycemia and hypoglycemia during the infusion period.
DISCUSSION
This trial will characterize the effects of early enteral dextrose on endogenous endocrine pathways and the systemic inflammatory response in sepsis. The results of this trial will inform future larger interventional studies of early enteral nutrients in critically ill patients with sepsis.
Identifiants
pubmed: 31148210
doi: 10.1002/jpen.1608
pmc: PMC6884652
mid: NIHMS1029517
doi:
Substances chimiques
Gastric Inhibitory Polypeptide
59392-49-3
Glucose
IY9XDZ35W2
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
541-547Subventions
Organisme : NHLBI NIH HHS
ID : K23 HL139987
Pays : United States
Organisme : NHLBI NIH HHS
ID : P01 HL114453
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000005
Pays : United States
Organisme : NIGMS NIH HHS
ID : K23 GM122069
Pays : United States
Informations de copyright
© 2019 American Society for Parenteral and Enteral Nutrition.
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