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A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the SPIRIT trial

BACKGROUND: Diarrhea is frequent in patients in intensive care units (ICU) and is associated with discomfort and complications and may increase the length of stay and nursing workload. METHODS: This was a prospective, double-blind, randomized, controlled single-center pilot study to assess the incid...

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Autores principales: Jakob, Stephan M., Bütikofer, Lukas, Berger, David, Coslovsky, Michael, Takala, Jukka
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466775/
https://www.ncbi.nlm.nih.gov/pubmed/28599662
http://dx.doi.org/10.1186/s13054-017-1730-1
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author Jakob, Stephan M.
Bütikofer, Lukas
Berger, David
Coslovsky, Michael
Takala, Jukka
author_facet Jakob, Stephan M.
Bütikofer, Lukas
Berger, David
Coslovsky, Michael
Takala, Jukka
author_sort Jakob, Stephan M.
collection PubMed
description BACKGROUND: Diarrhea is frequent in patients in intensive care units (ICU) and is associated with discomfort and complications and may increase the length of stay and nursing workload. METHODS: This was a prospective, double-blind, randomized, controlled single-center pilot study to assess the incidence and frequency of diarrhea and the respective effects of a modified enteral diet (intervention: Peptamen® AF, rich in proteins, medium chain triglycerides and fish oil) compared to a standard diet (control: Isosource® Energy) in 90 randomized adult patients (intervention, n = 46; control, n = 44) with an ICU stay ≥5 days and tube feeding ≥3 days. Tube feeding was initiated within 72 h of ICU admission and continued up to 10 days. The caloric goal was adjusted to needs by indirect calorimetry. Gastrointestinal function, nutritional intake, and nursing workload were recorded. Follow-up was until 28 days after randomization. RESULTS: Median age was 63.3 (interquartile range (IQR) 51.0–73.2) years and Simplified Acute Physiology Score (SAPS) II was 61.0 (IQR 47.8–74). Time to reach caloric goal (intervention: 2.2 (0.8–3.7) days (median, IQR); control: 2.0 (1.3–2.7) days; p = 0.16), length of time on study nutrition (intervention: 5.0 (3.6–6.4) days; control: 7.0 (5.3–8.7) days; p = 0.26), and calorie intake (intervention: 18.0 (12.5–20.9) kcal/kg/day; control 19.7 (17.3–23.1) kcal/kg/day; p = 0.08) did not differ between groups, with a higher protein intake for Peptamen® group (1.13 (0.78–1.31) g/kg/day vs 0.80 (0.70–0.94); p < 0.001). No difference in diarrhea incidence (intervention group: 29 (64%); control group: 31 (70%); p = 0.652), use of fecal collectors (23 (51%) vs. 24 (55%); p = 0.83), or diarrhea-free days (161 (64%) vs 196 (68%); p = 0.65) was found. Nursing workload and cost for diarrhea care were not different between the groups. In a post-hoc analysis, adjusted for treatment group, age, sex, and SAPS II score, diarrhea was associated with length of mechanical ventilation (9.5 (6.0–13.1) vs. 3.9 (3.2–4.6) days; p = 0.006) and length of ICU stay (11.0 (8.9–13.1) vs. 5.0 (3.8–6.2) days; p = 0.001). CONCLUSIONS: In this pilot study, we found a high incidence of diarrhea, which was not attenuated by Peptamen® AF. Patients with diarrhea stayed longer in the ICU. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01581957. Registered on 18 April 2012. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13054-017-1730-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-54667752017-06-14 A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the SPIRIT trial Jakob, Stephan M. Bütikofer, Lukas Berger, David Coslovsky, Michael Takala, Jukka Crit Care Research BACKGROUND: Diarrhea is frequent in patients in intensive care units (ICU) and is associated with discomfort and complications and may increase the length of stay and nursing workload. METHODS: This was a prospective, double-blind, randomized, controlled single-center pilot study to assess the incidence and frequency of diarrhea and the respective effects of a modified enteral diet (intervention: Peptamen® AF, rich in proteins, medium chain triglycerides and fish oil) compared to a standard diet (control: Isosource® Energy) in 90 randomized adult patients (intervention, n = 46; control, n = 44) with an ICU stay ≥5 days and tube feeding ≥3 days. Tube feeding was initiated within 72 h of ICU admission and continued up to 10 days. The caloric goal was adjusted to needs by indirect calorimetry. Gastrointestinal function, nutritional intake, and nursing workload were recorded. Follow-up was until 28 days after randomization. RESULTS: Median age was 63.3 (interquartile range (IQR) 51.0–73.2) years and Simplified Acute Physiology Score (SAPS) II was 61.0 (IQR 47.8–74). Time to reach caloric goal (intervention: 2.2 (0.8–3.7) days (median, IQR); control: 2.0 (1.3–2.7) days; p = 0.16), length of time on study nutrition (intervention: 5.0 (3.6–6.4) days; control: 7.0 (5.3–8.7) days; p = 0.26), and calorie intake (intervention: 18.0 (12.5–20.9) kcal/kg/day; control 19.7 (17.3–23.1) kcal/kg/day; p = 0.08) did not differ between groups, with a higher protein intake for Peptamen® group (1.13 (0.78–1.31) g/kg/day vs 0.80 (0.70–0.94); p < 0.001). No difference in diarrhea incidence (intervention group: 29 (64%); control group: 31 (70%); p = 0.652), use of fecal collectors (23 (51%) vs. 24 (55%); p = 0.83), or diarrhea-free days (161 (64%) vs 196 (68%); p = 0.65) was found. Nursing workload and cost for diarrhea care were not different between the groups. In a post-hoc analysis, adjusted for treatment group, age, sex, and SAPS II score, diarrhea was associated with length of mechanical ventilation (9.5 (6.0–13.1) vs. 3.9 (3.2–4.6) days; p = 0.006) and length of ICU stay (11.0 (8.9–13.1) vs. 5.0 (3.8–6.2) days; p = 0.001). CONCLUSIONS: In this pilot study, we found a high incidence of diarrhea, which was not attenuated by Peptamen® AF. Patients with diarrhea stayed longer in the ICU. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01581957. Registered on 18 April 2012. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13054-017-1730-1) contains supplementary material, which is available to authorized users. BioMed Central 2017-06-10 /pmc/articles/PMC5466775/ /pubmed/28599662 http://dx.doi.org/10.1186/s13054-017-1730-1 Text en © The Author(s). 2017 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
Jakob, Stephan M.
Bütikofer, Lukas
Berger, David
Coslovsky, Michael
Takala, Jukka
A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the SPIRIT trial
title A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the SPIRIT trial
title_full A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the SPIRIT trial
title_fullStr A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the SPIRIT trial
title_full_unstemmed A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the SPIRIT trial
title_short A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the SPIRIT trial
title_sort randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the spirit trial
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466775/
https://www.ncbi.nlm.nih.gov/pubmed/28599662
http://dx.doi.org/10.1186/s13054-017-1730-1
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