Very high intact-protein formula successfully provides protein intake according to nutritional recommendations in overweight critically ill patients: a double-blind randomized trial

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Abstract

Background

Optimal energy and protein provision through enteral nutrition is essential for critically ill patients. However, in clinical practice, the intake achieved is often far below the recommended targets. Because no polymeric formula with sufficient protein content is available, adequate protein intake can be achieved only by supplemental amino acids or semi-elemental formula administration. In the present study, we investigated whether protein intake can be increased with a new, very high intact-protein formula (VHPF) for enteral feeding.

Methods

In this randomized, controlled, double-blind, multicenter trial, 44 overweight (body mass index ≥ 25 kg/m ²) intensive care unit patients received either a VHPF (8 g/100 kcal) or a commercially available standard high protein formula (SHPF) (5 g/100 kcal). Protein and energy intake, gastrointestinal tolerance (gastric residual volume, vomiting, diarrhea, and constipation), adverse events, and serious adverse events were recorded. Total serum amino acid levels were measured at baseline and day 5.

Results

The primary outcome, protein intake at day 5, was 1.49 g/kg body weight (95% CI 1.21–1.78) and 0.76 g/kg body weight (95% CI 0.49–1.03, P < 0.001) for VHPF and SHPF, respectively. Daily protein intake was statistically significantly higher in the VHPF group compared with the SHPF group from day 2 to day 10. Protein intake in the VHPF group as a percentage of target (1.5 g/kg ideal body weight) was 74.7% (IQR 53.2–87.6%) and 111.6% (IQR 51.7–130.7%) during days 1–3 and days 4–10, respectively. Serum amino acid concentrations were higher at day 5 in the VHPF group than in the SHPF group ( P = 0.031). No differences were found in energy intake, measures of gastrointestinal tolerance, and safety.

Conclusions

Enteral feeding with VHPF (8 g/100 kcal) resulted in higher protein intake and plasma amino acid concentrations than an isocaloric SHPF (5 g/100 kcal), without an increase in energy intake. This VHPF facilitates feeding according to nutritional guidelines and is suitable as a first-line nutritional treatment for critically ill overweight patients.

Trial registration

Netherlands Trial Register, NTR5643. Registered on 2 February 2016.

Electronic supplementary material

The online version of this article (10.1186/s13054-018-2070-5) contains supplementary material, which is available to authorized users.

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Most cited references 29

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ESPEN Guidelines on Enteral Nutrition: Intensive care.

K. G. Kreymann, M Berger, N Deutz … (2006)

Enteral nutrition (EN) via tube feeding is, today, the preferred way of feeding the critically ill patient and an important means of counteracting for the catabolic state induced by severe diseases. These guidelines are intended to give evidence-based recommendations for the use of EN in patients who have a complicated course during their ICU stay, focusing particularly on those who develop a severe inflammatory response, i.e. patients who have failure of at least one organ during their ICU stay. These guidelines were developed by an interdisciplinary expert group in accordance with officially accepted standards and are based on all relevant publications since 1985. They were discussed and accepted in a consensus conference. EN should be given to all ICU patients who are not expected to be taking a full oral diet within three days. It should have begun during the first 24h using a standard high-protein formula. During the acute and initial phases of critical illness an exogenous energy supply in excess of 20-25 kcal/kg BW/day should be avoided, whereas, during recovery, the aim should be to provide values of 25-30 total kcal/kg BW/day. Supplementary parenteral nutrition remains a reserve tool and should be given only to those patients who do not reach their target nutrient intake on EN alone. There is no general indication for immune-modulating formulae in patients with severe illness or sepsis and an APACHE II Score >15. Glutamine should be supplemented in patients suffering from burns or trauma.

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The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study.

Cathy Alberda, Leah Gramlich, Naomi Jones … (2009)

The objective of this study was to examine the relationship between the amount of energy and protein administered and clinical outcomes, and the extent to which pre-morbid nutritional status influenced this relationship. We conducted an observational cohort study of nutrition practices in 167 intensive care units (ICUs) across 21 [corrected] countries. Patient demographics were collected, and the type and amount of nutrition received were recorded daily for a maximum of 12 days. Patients were followed prospectively to determine 60-day mortality and ventilator-free days (VFDs). We used body mass index (BMI, kg/m2) as a marker of nutritional status prior to ICU admission. Regression models were developed to evaluate the relationship between nutrition received and 60-day mortality and VFDs, and to examine how BMI modifies this relationship. Data were collected on 2,772 mechanically ventilated patients who received an average of 1,034 kcal/day and 47 g protein/day. An increase of 1,000 cal per day was associated with reduced mortality [odds ratio for 60-day mortality 0.76; 95% confidence intervals (CI) 0.61-0.95, p = 0.014] and an increased number of VFDs (3.5 VFD, 95% CI 1.2-5.9, p = 0.003). The effect of increased calories associated with lower mortality was observed in patients with a BMI or =35 with no benefit for patients with a BMI 25 to or =35.

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Early high protein intake is associated with low mortality and energy overfeeding with high mortality in non-septic mechanically ventilated critically ill patients

Peter Weijs, Wilhelmus GPM Looijaard, Albertus Beishuizen … (2014)

Introduction Early protein and energy feeding in critically ill patients is heavily debated and early protein feeding hardly studied. Methods A prospective database with mixed medical-surgical critically ill patients with prolonged mechanical ventilation (>72 hours) and measured energy expenditure was used in this study. Logistic regression analysis was used to analyse the relation between admission day-4 protein intake group (with cutoffs 0.8, 1.0, and 1.2 g/kg), energy overfeeding (ratio energy intake/measured energy expenditure > 1.1), and admission diagnosis of sepsis with hospital mortality after adjustment for APACHE II (Acute Physiology and Chronic Health Evaluation II) score. Results A total of 843 patients were included. Of these, 117 had sepsis. Of the 736 non-septic patients 307 were overfed. Mean day-4 protein intake was 1.0 g/kg pre-admission weight per day and hospital mortality was 36%. In the total cohort, day-4 protein intake group (odds ratio (OR) 0.85; 95% confidence interval (CI) 0.73 to 0.99; P = 0.047), energy overfeeding (OR 1.62; 95%CI 1.07 to 2.44; P = 0.022), and sepsis (OR 1.77; 95%CI 1.18 to 2.65; P = 0.005) were independent risk factors for mortality besides APACHE II score. In patients with sepsis or energy overfeeding, day-4 protein intake was not associated with mortality. For non-septic, non-overfed patients (n = 419), mortality decreased with higher protein intake group: 37% for <0.8 g/kg, 35% for 0.8 to 1.0 g/kg, 27% for 1.0 to 1.2 g/kg, and 19% for ≥1.2 g/kg (P = 0.033). For these, a protein intake level of ≥1.2 g/kg was significantly associated with lower mortality (OR 0.42, 95%CI 0.21 to 0.83, P = 0.013). Conclusions In non-septic critically ill patients, early high protein intake was associated with lower mortality and early energy overfeeding with higher mortality. In septic patients early high protein intake had no beneficial effect on mortality. Electronic supplementary material The online version of this article (doi:10.1186/s13054-014-0701-z) contains supplementary material, which is available to authorized users.

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Author and article information

Contributors

Arthur R. H. van Zanten: +31-318-43115 , zantena@zgv.nl

Journal

Journal ID (nlm-ta): Crit Care

Title: Critical Care

Publisher: BioMed Central (London )

ISSN (Print): 1364-8535

ISSN (Electronic): 1466-609X

Publication date (Electronic): 12 June 2018

Publication date PMC-release: 12 June 2018

Publication date Collection: 2018

Volume: 22

Electronic Location Identifier: 156

Affiliations

[1 ]ISNI 0000 0004 0398 026X, GRID grid.415351.7, Department of Intensive Care Medicine, , Gelderse Vallei Hospital, ; Ede, The Netherlands

[2 ]ISNI 0000 0004 0593 7118, GRID grid.42399.35, Surgical and Trauma Intensive Care Unit, , Pellegrin University Hospital, ; Bordeaux, France

[3 ]ISNI 0000 0004 0626 3303, GRID grid.410566.0, Department of Critical Care Medicine, , Ghent University Hospital, ; Ghent, Belgium

[4 ]ISNI 0000 0001 0547 5927, GRID grid.452600.5, Department of Intensive Care, , Isala Hospital, ; Zwolle, The Netherlands

[5 ]ISNI 0000 0004 4675 6663, GRID grid.468395.5, Nutricia Research, ; Utrecht, The Netherlands

Article

Publisher ID: 2070

DOI: 10.1186/s13054-018-2070-5

PMC ID: 5998555

PubMed ID: 29895309

SO-VID: e37f8a09-7948-4c7f-8807-151f113a9ef4

License:

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.

History

Date received : 16 March 2018

Date accepted : 17 May 2018

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100007772, Danone Research Centre for Specialised Nutrition;

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ScienceOpen disciplines: Emergency medicine & Trauma

Keywords: icu,enteral nutrition,high protein,nutritional guidelines,intact protein

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ScienceOpen disciplines: Emergency medicine & Trauma

Keywords: icu, enteral nutrition, high protein, nutritional guidelines, intact protein

Very high intact-protein formula successfully provides protein intake according to nutritional recommendations in overweight critically ill patients: a double-blind randomized trial

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Abstract

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Methods

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Conclusions

Trial registration

Electronic supplementary material

Related collections

Irish Journal of Paramedicine

Most cited references 29

ESPEN Guidelines on Enteral Nutrition: Intensive care.

The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study.

Early high protein intake is associated with low mortality and energy overfeeding with high mortality in non-septic mechanically ventilated critically ill patients

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