A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis

OBJECTIVES:. Preclinical studies from our laboratory demonstrated therapeutic effects of enteral dextrose administration in the acute phase of sepsis, mediated by the intestine-derived incretin hormone glucose-dependent insulinotropic peptide. The current study investigated the effects of an early e...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Faraaz Ali Shah, MD, MPH, Georgios D. Kitsios, MD, PhD, Sachin Yende, MD, MS, Daniel G. Dunlap, MD, Denise Scholl, CRC, Byron Chuan, MS, Nameer Al-Yousif, MD, Yingze Zhang, PhD, Seyed Mehdi Nouraie, MD, PhD, Alison Morris, MD, MS, David T. Huang, MD, MPH, Christopher P. O’Donnell, PhD, Bryan J. McVerry, MD
Formato:	article
Lenguaje:	EN
Publicado:	Wolters Kluwer 2021
Materias:	Medical emergencies. Critical care. Intensive care. First aid RC86-88.9
Acceso en línea:	https://doaj.org/article/7ee595d7e5914568a24a492c5f3d9bb7
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:7ee595d7e5914568a24a492c5f3d9bb7
record_format	dspace
spelling	oai:doaj.org-article:7ee595d7e5914568a24a492c5f3d9bb72021-11-25T07:56:43ZA Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis2639-802810.1097/CCE.0000000000000550https://doaj.org/article/7ee595d7e5914568a24a492c5f3d9bb72021-10-01T00:00:00Zhttp://journals.lww.com/10.1097/CCE.0000000000000550https://doaj.org/toc/2639-8028OBJECTIVES:. Preclinical studies from our laboratory demonstrated therapeutic effects of enteral dextrose administration in the acute phase of sepsis, mediated by the intestine-derived incretin hormone glucose-dependent insulinotropic peptide. The current study investigated the effects of an early enteral dextrose infusion on systemic inflammation and glucose metabolism in critically ill septic patients. DESIGN:. Single-center, double-blind, placebo-controlled randomized pilot clinical trial (NCT03454087). SETTING:. Tertiary-care medical center in Pittsburgh, PA. PATIENTS:. Critically ill adult patients within 48 hours of sepsis diagnosis and with established enteral access. INTERVENTIONS:. Participants were randomized 1:1 to receive a continuous water (placebo) or enteral dextrose infusion (50% dextrose; 0.5 g/mL) at 10 mL per hour for 24 hours. MEASUREMENTS AND MAIN RESULTS:. We randomized 58 participants between June 2018 and January 2020 (placebo: n = 29, dextrose: n = 29). Protocol adherence was high with similar duration of study infusion in the placebo (median duration, 24 hr [interquartile range, 20.9–24 hr]) and dextrose (23.9 hr [23–24 hr]) groups (p = 0.59). The primary outcome of circulating interleukin-6 at end-infusion did not differ between the dextrose (median, 32 pg/mL [19–79 pg/mL]) and placebo groups (24 pg/mL [9–59 pg/mL]; p = 0.13) with similar results in other measures of the systemic host immune response. Enteral dextrose increased circulating glucose-dependent insulinotropic peptide (76% increase; 95% CI [35–119]; p < 0.01) and insulin (53% [17–88]; p < 0.01) compared with placebo consistent with preclinical studies, but also increased blood glucose during the 24-hour infusion period (153 mg/dL [119–223] vs 116 mg/dL [91–140]; p < 0.01). Occurrence of emesis, ICU and hospital length of stay, and 30-day mortality did not differ between the placebo and enteral dextrose groups. CONCLUSIONS:. Early infusion of low-level enteral dextrose in critically ill septic patients increased circulating levels of insulin and the incretin hormone glucose-dependent insulinotropic peptide without decreasing systemic inflammation.Faraaz Ali Shah, MD, MPHGeorgios D. Kitsios, MD, PhDSachin Yende, MD, MSDaniel G. Dunlap, MDDenise Scholl, CRCByron Chuan, MSNameer Al-Yousif, MDYingze Zhang, PhDSeyed Mehdi Nouraie, MD, PhDAlison Morris, MD, MSDavid T. Huang, MD, MPHChristopher P. O’Donnell, PhDBryan J. McVerry, MDWolters KluwerarticleMedical emergencies. Critical care. Intensive care. First aidRC86-88.9ENCritical Care Explorations, Vol 3, Iss 10, p e550 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical emergencies. Critical care. Intensive care. First aid RC86-88.9
spellingShingle	Medical emergencies. Critical care. Intensive care. First aid RC86-88.9 Faraaz Ali Shah, MD, MPH Georgios D. Kitsios, MD, PhD Sachin Yende, MD, MS Daniel G. Dunlap, MD Denise Scholl, CRC Byron Chuan, MS Nameer Al-Yousif, MD Yingze Zhang, PhD Seyed Mehdi Nouraie, MD, PhD Alison Morris, MD, MS David T. Huang, MD, MPH Christopher P. O’Donnell, PhD Bryan J. McVerry, MD A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis
description	OBJECTIVES:. Preclinical studies from our laboratory demonstrated therapeutic effects of enteral dextrose administration in the acute phase of sepsis, mediated by the intestine-derived incretin hormone glucose-dependent insulinotropic peptide. The current study investigated the effects of an early enteral dextrose infusion on systemic inflammation and glucose metabolism in critically ill septic patients. DESIGN:. Single-center, double-blind, placebo-controlled randomized pilot clinical trial (NCT03454087). SETTING:. Tertiary-care medical center in Pittsburgh, PA. PATIENTS:. Critically ill adult patients within 48 hours of sepsis diagnosis and with established enteral access. INTERVENTIONS:. Participants were randomized 1:1 to receive a continuous water (placebo) or enteral dextrose infusion (50% dextrose; 0.5 g/mL) at 10 mL per hour for 24 hours. MEASUREMENTS AND MAIN RESULTS:. We randomized 58 participants between June 2018 and January 2020 (placebo: n = 29, dextrose: n = 29). Protocol adherence was high with similar duration of study infusion in the placebo (median duration, 24 hr [interquartile range, 20.9–24 hr]) and dextrose (23.9 hr [23–24 hr]) groups (p = 0.59). The primary outcome of circulating interleukin-6 at end-infusion did not differ between the dextrose (median, 32 pg/mL [19–79 pg/mL]) and placebo groups (24 pg/mL [9–59 pg/mL]; p = 0.13) with similar results in other measures of the systemic host immune response. Enteral dextrose increased circulating glucose-dependent insulinotropic peptide (76% increase; 95% CI [35–119]; p < 0.01) and insulin (53% [17–88]; p < 0.01) compared with placebo consistent with preclinical studies, but also increased blood glucose during the 24-hour infusion period (153 mg/dL [119–223] vs 116 mg/dL [91–140]; p < 0.01). Occurrence of emesis, ICU and hospital length of stay, and 30-day mortality did not differ between the placebo and enteral dextrose groups. CONCLUSIONS:. Early infusion of low-level enteral dextrose in critically ill septic patients increased circulating levels of insulin and the incretin hormone glucose-dependent insulinotropic peptide without decreasing systemic inflammation.
format	article
author	Faraaz Ali Shah, MD, MPH Georgios D. Kitsios, MD, PhD Sachin Yende, MD, MS Daniel G. Dunlap, MD Denise Scholl, CRC Byron Chuan, MS Nameer Al-Yousif, MD Yingze Zhang, PhD Seyed Mehdi Nouraie, MD, PhD Alison Morris, MD, MS David T. Huang, MD, MPH Christopher P. O’Donnell, PhD Bryan J. McVerry, MD
author_facet	Faraaz Ali Shah, MD, MPH Georgios D. Kitsios, MD, PhD Sachin Yende, MD, MS Daniel G. Dunlap, MD Denise Scholl, CRC Byron Chuan, MS Nameer Al-Yousif, MD Yingze Zhang, PhD Seyed Mehdi Nouraie, MD, PhD Alison Morris, MD, MS David T. Huang, MD, MPH Christopher P. O’Donnell, PhD Bryan J. McVerry, MD
author_sort	Faraaz Ali Shah, MD, MPH
title	A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis
title_short	A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis
title_full	A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis
title_fullStr	A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis
title_full_unstemmed	A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis
title_sort	pilot double-blind placebo-controlled randomized clinical trial to investigate the effects of early enteral nutrients in sepsis
publisher	Wolters Kluwer
publishDate	2021
url	https://doaj.org/article/7ee595d7e5914568a24a492c5f3d9bb7
work_keys_str_mv	AT faraazalishahmdmph apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT georgiosdkitsiosmdphd apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT sachinyendemdms apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT danielgdunlapmd apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT deniseschollcrc apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT byronchuanms apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT nameeralyousifmd apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT yingzezhangphd apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT seyedmehdinouraiemdphd apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT alisonmorrismdms apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT davidthuangmdmph apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT christopherpodonnellphd apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT bryanjmcverrymd apilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT faraazalishahmdmph pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT georgiosdkitsiosmdphd pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT sachinyendemdms pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT danielgdunlapmd pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT deniseschollcrc pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT byronchuanms pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT nameeralyousifmd pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT yingzezhangphd pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT seyedmehdinouraiemdphd pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT alisonmorrismdms pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT davidthuangmdmph pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT christopherpodonnellphd pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis AT bryanjmcverrymd pilotdoubleblindplacebocontrolledrandomizedclinicaltrialtoinvestigatetheeffectsofearlyenteralnutrientsinsepsis
_version_	1718413628836675584

A Pilot Double-Blind Placebo-Controlled Randomized Clinical Trial to Investigate the Effects of Early Enteral Nutrients in Sepsis

Ejemplares similares