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Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial

BACKGROUND: Adequate nutrition of critically ill patients plays a key role in the modulation of metabolic response to stress. OBJECTIVE: This paper presents the development of a protocol for a randomized controlled trial (RCT) aimed at comparing clinical outcomes of patients in the intensive care un...

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Autores principales: Danielis, Matteo, Lorenzoni, Giulia, Cavaliere, Laura, Ruffolo, Mariangela, Peressoni, Luca, De Monte, Amato, Muzzi, Rodolfo, Beltrame, Fabio, Gregori, Dario
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5442349/
https://www.ncbi.nlm.nih.gov/pubmed/28487264
http://dx.doi.org/10.2196/resprot.7100
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author Danielis, Matteo
Lorenzoni, Giulia
Cavaliere, Laura
Ruffolo, Mariangela
Peressoni, Luca
De Monte, Amato
Muzzi, Rodolfo
Beltrame, Fabio
Gregori, Dario
author_facet Danielis, Matteo
Lorenzoni, Giulia
Cavaliere, Laura
Ruffolo, Mariangela
Peressoni, Luca
De Monte, Amato
Muzzi, Rodolfo
Beltrame, Fabio
Gregori, Dario
author_sort Danielis, Matteo
collection PubMed
description BACKGROUND: Adequate nutrition of critically ill patients plays a key role in the modulation of metabolic response to stress. OBJECTIVE: This paper presents the development of a protocol for a randomized controlled trial (RCT) aimed at comparing clinical outcomes of patients in the intensive care unit (ICU) administered with standard and protein-fortified diet. Together with the RCT study protocol, the results of the observational analysis conducted to assess the feasibility of the RCT are presented. METHODS: An RCT on adult patients admitted to ICU and undergoing mechanical ventilation in the absence of renal or hepatic failure will be conducted. Patients enrolled will be randomized with an allocation rate of 1:1 at standard diet versus protein-fortified diet. The estimated sample size is 19 per arm, for a total of 38 patients to be randomized. RESULTS: Enrollment began in January 2017. In the feasibility study, 14 patients were enrolled. Protein administration increased significantly (P<.001) over time but was significantly lower compared to that recommended (P<.001). Blood urea nitrogen significantly increased (P<.03) over the period of observation. Such increased catabolism resulted in negative cumulative nitrogen balance (NB) in all patients, and some patients presented with a more negative NB compared to the others. CONCLUSIONS: Results of the feasibility study clearly confirmed that protein provision in ICU patients is below that recommended and that this results in impaired NB. The emerging of an interindividual variability in NB will be further analyzed in the RCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT02990065; https://clinicaltrials.gov/ct2/show/NCT02990065 (Archived by WebCite at http://www.webcitation.org/6prsqZdRM).
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spelling pubmed-54423492017-06-06 Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial Danielis, Matteo Lorenzoni, Giulia Cavaliere, Laura Ruffolo, Mariangela Peressoni, Luca De Monte, Amato Muzzi, Rodolfo Beltrame, Fabio Gregori, Dario JMIR Res Protoc Protocol BACKGROUND: Adequate nutrition of critically ill patients plays a key role in the modulation of metabolic response to stress. OBJECTIVE: This paper presents the development of a protocol for a randomized controlled trial (RCT) aimed at comparing clinical outcomes of patients in the intensive care unit (ICU) administered with standard and protein-fortified diet. Together with the RCT study protocol, the results of the observational analysis conducted to assess the feasibility of the RCT are presented. METHODS: An RCT on adult patients admitted to ICU and undergoing mechanical ventilation in the absence of renal or hepatic failure will be conducted. Patients enrolled will be randomized with an allocation rate of 1:1 at standard diet versus protein-fortified diet. The estimated sample size is 19 per arm, for a total of 38 patients to be randomized. RESULTS: Enrollment began in January 2017. In the feasibility study, 14 patients were enrolled. Protein administration increased significantly (P<.001) over time but was significantly lower compared to that recommended (P<.001). Blood urea nitrogen significantly increased (P<.03) over the period of observation. Such increased catabolism resulted in negative cumulative nitrogen balance (NB) in all patients, and some patients presented with a more negative NB compared to the others. CONCLUSIONS: Results of the feasibility study clearly confirmed that protein provision in ICU patients is below that recommended and that this results in impaired NB. The emerging of an interindividual variability in NB will be further analyzed in the RCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT02990065; https://clinicaltrials.gov/ct2/show/NCT02990065 (Archived by WebCite at http://www.webcitation.org/6prsqZdRM). JMIR Publications 2017-05-09 /pmc/articles/PMC5442349/ /pubmed/28487264 http://dx.doi.org/10.2196/resprot.7100 Text en ©Matteo Danielis, Giulia Lorenzoni, Laura Cavaliere, Mariangela Ruffolo, Luca Peressoni, Amato De Monte, Rodolfo Muzzi, Fabio Beltrame, Dario Gregori. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.05.2017. http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Danielis, Matteo
Lorenzoni, Giulia
Cavaliere, Laura
Ruffolo, Mariangela
Peressoni, Luca
De Monte, Amato
Muzzi, Rodolfo
Beltrame, Fabio
Gregori, Dario
Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial
title Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial
title_full Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial
title_fullStr Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial
title_full_unstemmed Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial
title_short Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial
title_sort optimizing protein intake and nitrogen balance (opinib) in adult critically ill patients: a study protocol for a randomized controlled trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5442349/
https://www.ncbi.nlm.nih.gov/pubmed/28487264
http://dx.doi.org/10.2196/resprot.7100
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