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Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study

INTRODUCTION: Although standard enteral nutrition is universally accepted, the use of disease-specific formulas for hyperglycemic patients is still controversial. This study examines whether a high-protein diabetes-specific formula reduces insulin needs, improves glycemic control and reduces ICU-acq...

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Autores principales: Mesejo, Alfonso, Montejo-González, Juan Carlos, Vaquerizo-Alonso, Clara, Lobo-Tamer, Gabriela, Zabarte-Martinez, Mercedes, Herrero-Meseguer, Jose Ignacio, Acosta-Escribano, Jose, Blesa-Malpica, Antonio, Martinez-Lozano, Fátima
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4638090/
https://www.ncbi.nlm.nih.gov/pubmed/26549276
http://dx.doi.org/10.1186/s13054-015-1108-1
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author Mesejo, Alfonso
Montejo-González, Juan Carlos
Vaquerizo-Alonso, Clara
Lobo-Tamer, Gabriela
Zabarte-Martinez, Mercedes
Herrero-Meseguer, Jose Ignacio
Acosta-Escribano, Jose
Blesa-Malpica, Antonio
Martinez-Lozano, Fátima
author_facet Mesejo, Alfonso
Montejo-González, Juan Carlos
Vaquerizo-Alonso, Clara
Lobo-Tamer, Gabriela
Zabarte-Martinez, Mercedes
Herrero-Meseguer, Jose Ignacio
Acosta-Escribano, Jose
Blesa-Malpica, Antonio
Martinez-Lozano, Fátima
author_sort Mesejo, Alfonso
collection PubMed
description INTRODUCTION: Although standard enteral nutrition is universally accepted, the use of disease-specific formulas for hyperglycemic patients is still controversial. This study examines whether a high-protein diabetes-specific formula reduces insulin needs, improves glycemic control and reduces ICU-acquired infection in critically ill, hyperglycemic patients on mechanical ventilation (MV). METHODS: This was a prospective, open-label, randomized (web-based, blinded) study conducted at nine Spanish ICUs. The patient groups established according to the high-protein formula received were: group A, new-generation diabetes-specific formula; group B, standard control formula; group C, control diabetes-specific formula. Inclusion criteria were: expected enteral nutrition ≥5 days, MV, baseline glucose >126 mg/dL on admission or >200 mg/dL in the first 48 h. Exclusion criteria were: APACHE II ≤10, insulin-dependent diabetes, renal or hepatic failure, treatment with corticosteroids, immunosuppressants or lipid-lowering drugs and body mass index ≥40 kg/m(2). The targeted glucose level was 110–150 mg/dL. Glycemic variability was calculated as the standard deviation, glycemic lability index and coefficient of variation. Acquired infections were recorded using published consensus criteria for critically ill patients. Data analysis was on an intention-to-treat basis. RESULTS: Over a 2-year period, 157 patients were consecutively enrolled (A 52, B 53 and C 52). Compared with the standard control formula, the new formula gave rise to lower insulin requirement (19.1 ± 13.1 vs. 23.7 ± 40.1 IU/day, p <0.05), plasma glucose (138.6 ± 39.1 vs. 146.1 ± 49.9 mg/dL, p <0.01) and capillary blood glucose (146.1 ± 45.8 vs. 155.3 ± 63.6 mg/dL, p <0.001). Compared with the control diabetes-specific formula, only capillary glucose levels were significantly reduced (146.1 ± 45.8 vs. 150.1 ± 41.9, p <0.01). Both specific formulas reduced capillary glucose on ICU day 1 (p <0.01), glucose variability in the first week (p <0.05), and incidences of ventilator-associated tracheobronchitis (p <0.01) or pneumonia (p <0.05) compared with the standard formula. No effects of the nutrition formula were produced on hospital stay or mortality. CONCLUSIONS: In these high-risk ICU patients, both diabetes-specific formulas lowered insulin requirements, improved glycemic control and reduced the risk of acquired infections relative to the standard formula. Compared with the control-specific formula, the new-generation formula also improved capillary glycemia. TRIAL REGISTRATION: Clinicaltrials.gov NCT1233726. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13054-015-1108-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-46380902015-11-10 Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study Mesejo, Alfonso Montejo-González, Juan Carlos Vaquerizo-Alonso, Clara Lobo-Tamer, Gabriela Zabarte-Martinez, Mercedes Herrero-Meseguer, Jose Ignacio Acosta-Escribano, Jose Blesa-Malpica, Antonio Martinez-Lozano, Fátima Crit Care Research INTRODUCTION: Although standard enteral nutrition is universally accepted, the use of disease-specific formulas for hyperglycemic patients is still controversial. This study examines whether a high-protein diabetes-specific formula reduces insulin needs, improves glycemic control and reduces ICU-acquired infection in critically ill, hyperglycemic patients on mechanical ventilation (MV). METHODS: This was a prospective, open-label, randomized (web-based, blinded) study conducted at nine Spanish ICUs. The patient groups established according to the high-protein formula received were: group A, new-generation diabetes-specific formula; group B, standard control formula; group C, control diabetes-specific formula. Inclusion criteria were: expected enteral nutrition ≥5 days, MV, baseline glucose >126 mg/dL on admission or >200 mg/dL in the first 48 h. Exclusion criteria were: APACHE II ≤10, insulin-dependent diabetes, renal or hepatic failure, treatment with corticosteroids, immunosuppressants or lipid-lowering drugs and body mass index ≥40 kg/m(2). The targeted glucose level was 110–150 mg/dL. Glycemic variability was calculated as the standard deviation, glycemic lability index and coefficient of variation. Acquired infections were recorded using published consensus criteria for critically ill patients. Data analysis was on an intention-to-treat basis. RESULTS: Over a 2-year period, 157 patients were consecutively enrolled (A 52, B 53 and C 52). Compared with the standard control formula, the new formula gave rise to lower insulin requirement (19.1 ± 13.1 vs. 23.7 ± 40.1 IU/day, p <0.05), plasma glucose (138.6 ± 39.1 vs. 146.1 ± 49.9 mg/dL, p <0.01) and capillary blood glucose (146.1 ± 45.8 vs. 155.3 ± 63.6 mg/dL, p <0.001). Compared with the control diabetes-specific formula, only capillary glucose levels were significantly reduced (146.1 ± 45.8 vs. 150.1 ± 41.9, p <0.01). Both specific formulas reduced capillary glucose on ICU day 1 (p <0.01), glucose variability in the first week (p <0.05), and incidences of ventilator-associated tracheobronchitis (p <0.01) or pneumonia (p <0.05) compared with the standard formula. No effects of the nutrition formula were produced on hospital stay or mortality. CONCLUSIONS: In these high-risk ICU patients, both diabetes-specific formulas lowered insulin requirements, improved glycemic control and reduced the risk of acquired infections relative to the standard formula. Compared with the control-specific formula, the new-generation formula also improved capillary glycemia. TRIAL REGISTRATION: Clinicaltrials.gov NCT1233726. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13054-015-1108-1) contains supplementary material, which is available to authorized users. BioMed Central 2015-11-09 2015 /pmc/articles/PMC4638090/ /pubmed/26549276 http://dx.doi.org/10.1186/s13054-015-1108-1 Text en © Mesejo et al. 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Mesejo, Alfonso
Montejo-González, Juan Carlos
Vaquerizo-Alonso, Clara
Lobo-Tamer, Gabriela
Zabarte-Martinez, Mercedes
Herrero-Meseguer, Jose Ignacio
Acosta-Escribano, Jose
Blesa-Malpica, Antonio
Martinez-Lozano, Fátima
Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study
title Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study
title_full Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study
title_fullStr Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study
title_full_unstemmed Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study
title_short Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study
title_sort diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4638090/
https://www.ncbi.nlm.nih.gov/pubmed/26549276
http://dx.doi.org/10.1186/s13054-015-1108-1
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