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, 6 (5), e78

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

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

Matteo Danielis et al. JMIR Res Protoc.

Abstract

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).

Keywords: catabolism; intensive care unit; mechanical ventilation; nitrogen balance; protein requirements.

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Flowchart of the study protocol.
Figure 2
Figure 2
Composition of the calories administered.
Figure 3
Figure 3
Protein intake trend.
Figure 4
Figure 4
Blood urea nitrogen trend.
Figure 5
Figure 5
Cumulative nitrogen balance during the first 72 hours.
Figure 6
Figure 6
Protein intake administered versus ideal protein target in the first 24 hours.

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References

    1. McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G, ASPEN Board of Directors. American College of Critical Care Medicine. Society of Critical Care Medicine Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (ASPEN) JPEN J Parenter Enteral Nutr. 2009;33(3):277–316. doi: 10.1177/0148607109335234. - DOI - PubMed
    1. McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C, Society of Critical Care Medicine. American Society for Parenteral and Enteral Nutrition Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (ASPEN) JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159–211. doi: 10.1177/0148607115621863. - DOI - PubMed
    1. Anders S, Albert R, Miller A, Weinger MB, Doig AK, Behrens M, Agutter J. Evaluation of an integrated graphical display to promote acute change detection in ICU patients. Int J Med Inform. 2012 Dec;81(12):842–851. doi: 10.1016/j.ijmedinf.2012.04.004. - DOI - PMC - PubMed
    1. Singer P, Anbar R, Cohen J, Shapiro H, Shalita-Chesner M, Lev S, Grozovski E, Theilla M, Frishman S, Madar Z. The tight calorie control study (TICACOS): a prospective, randomized, controlled pilot study of nutritional support in critically ill patients. Intensive Care Med. 2011 Apr;37(4):601–609. doi: 10.1007/s00134-011-2146-z. - DOI - PubMed
    1. Picolo MF, Lago AF, Menegueti MG, Nicolini EA, Basile-Filho A, Nunes AA, Martins-Filho OA, Auxiliadora-Martins M. Harris-Benedict equation and resting energy expenditure estimates in critically ill ventilator patients. Am J Crit Care. 2016 Jan;25(1):e21–e29. doi: 10.4037/ajcc2016758. - DOI - PubMed

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