Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial

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Abstract

Background

Nutrition is one of the fundamentals of care provided to critically ill adults. The volume of enteral nutrition received, however, is often much less than prescribed due to multiple functional and process issues. To deliver the prescribed volume and correct the energy deficit associated with enteral nutrition alone, parenteral nutrition can be used in combination (termed “supplemental parenteral nutrition”), but benefits of this method have not been firmly established. A multi-centre, randomised, clinical trial is currently underway to determine if prescribed energy requirements can be provided to critically ill patients by using a supplemental parenteral nutrition strategy in the critically ill.

Methods/design

This prospective, multi-centre, randomised, stratified, parallel-group, controlled, phase II trial aims to determine whether a supplemental parenteral nutrition strategy will reliably and safely increase energy intake when compared to usual care. The study will be conducted for 100 critically ill adults with at least one organ system failure and evidence of insufficient enteral intake from six intensive care units in Australia and New Zealand. Enrolled patients will be allocated to either a supplemental parenteral nutrition strategy for 7 days post randomisation or to usual care with enteral nutrition. The primary outcome will be the average energy amount delivered from nutrition therapy over the first 7 days of the study period. Secondary outcomes include protein delivery for 7 days post randomisation; total energy and protein delivery, antibiotic use and organ failure rates (up to 28 days); duration of ventilation, length of intensive care unit and hospital stay. At both intensive care unit and hospital discharge strength and health-related quality of life assessments will be undertaken. Study participants will be followed up for health-related quality of life, resource utilisation and survival at 90 and 180 days post randomisation (unless death occurs first).

Discussion

This trial aims to determine if provision of a supplemental parenteral nutrition strategy to critically ill adults will increase energy intake compared to usual care in Australia and New Zealand. Trial outcomes will guide development of a subsequent larger randomised controlled trial.

Trial registration

NCT01847534 (First registered 5 February 2013, last updated 14 October 2015)

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-015-1118-y) contains supplementary material, which is available to authorized users.

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Most cited references 12

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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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Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial.

Claudia Paula Heidegger, Mette Berger, Séverine Graf … (2013)

Enteral nutrition (EN) is recommended for patients in the intensive-care unit (ICU), but it does not consistently achieve nutritional goals. We assessed whether delivery of 100% of the energy target from days 4 to 8 in the ICU with EN plus supplemental parenteral nutrition (SPN) could optimise clinical outcome. This randomised controlled trial was undertaken in two centres in Switzerland. We enrolled patients on day 3 of admission to the ICU who had received less than 60% of their energy target from EN, were expected to stay for longer than 5 days, and to survive for longer than 7 days. We calculated energy targets with indirect calorimetry on day 3, or if not possible, set targets as 25 and 30 kcal per kg of ideal bodyweight a day for women and men, respectively. Patients were randomly assigned (1:1) by a computer-generated randomisation sequence to receive EN or SPN. The primary outcome was occurrence of nosocomial infection after cessation of intervention (day 8), measured until end of follow-up (day 28), analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00802503. We randomly assigned 153 patients to SPN and 152 to EN. 30 patients discontinued before the study end. Mean energy delivery between day 4 and 8 was 28 kcal/kg per day (SD 5) for the SPN group (103% [SD 18%] of energy target), compared with 20 kcal/kg per day (7) for the EN group (77% [27%]). Between days 9 and 28, 41 (27%) of 153 patients in the SPN group had a nosocomial infection compared with 58 (38%) of 152 patients in the EN group (hazard ratio 0·65, 95% CI 0·43-0·97; p=0·0338), and the SPN group had a lower mean number of nosocomial infections per patient (-0·42 [-0·79 to -0·05]; p=0·0248). Individually optimised energy supplementation with SPN starting 4 days after ICU admission could reduce nosocomial infections and should be considered as a strategy to improve clinical outcome in patients in the ICU for whom EN is insufficient. Foundation Nutrition 2000Plus, ICU Quality Funds, Baxter, and Fresenius Kabi. Copyright © 2013 Elsevier Ltd. All rights reserved.

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Trial of the route of early nutritional support in critically ill adults.

Danielle Bear, Sheila E Harvey, Francesca Parrott … (2014)

Uncertainty exists about the most effective route for delivery of early nutritional support in critically ill adults. We hypothesized that delivery through the parenteral route is superior to that through the enteral route. We conducted a pragmatic, randomized trial involving adults with an unplanned admission to one of 33 English intensive care units. We randomly assigned patients who could be fed through either the parenteral or the enteral route to a delivery route, with nutritional support initiated within 36 hours after admission and continued for up to 5 days. The primary outcome was all-cause mortality at 30 days. We enrolled 2400 patients; 2388 (99.5%) were included in the analysis (1191 in the parenteral group and 1197 in the enteral group). By 30 days, 393 of 1188 patients (33.1%) in the parenteral group and 409 of 1195 patients (34.2%) in the enteral group had died (relative risk in parenteral group, 0.97; 95% confidence interval, 0.86 to 1.08; P=0.57). There were significant reductions in the parenteral group, as compared with the enteral group, in rates of hypoglycemia (44 patients [3.7%] vs. 74 patients [6.2%]; P=0.006) and vomiting (100 patients [8.4%] vs. 194 patients [16.2%]; P<0.001). There were no significant differences between the parenteral group and the enteral group in the mean number of treated infectious complications (0.22 vs. 0.21; P=0.72), 90-day mortality (442 of 1184 patients [37.3%] vs. 464 of 1188 patients [39.1%], P=0.40), in rates of 14 other secondary outcomes, or in rates of adverse events. Caloric intake was similar in the two groups, with the target intake not achieved in most patients. We found no significant difference in 30-day mortality associated with the route of delivery of early nutritional support in critically ill adults. (Funded by the United Kingdom National Institute for Health Research; CALORIES Current Controlled Trials number, ISRCTN17386141.).

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Author and article information

Contributors

Emma J. Ridley: +61 4 3 9903 30555 , emma.ridley@monash.edu

Andrew R. Davies: andrew.davies@monash.edu

Rachael Parke: RParke@adhb.govt.nz

Michael Bailey: michael.bailey@monash.edu

Colin McArthur: ColinM@adhb.govt.nz

Lyn Gillanders: LynG@adhb.govt.nz

David J. Cooper: jamie.cooper@monash.edu

Shay McGuinness: ShayMc@adhb.govt.nz

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 24 December 2015

Publication date PMC-release: 24 December 2015

Publication date Collection: 2015

Volume: 16

Electronic Location Identifier: 587

Affiliations

[ ]Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventative Medicine, Monash University, Commercial Road, Melbourne, 3004 Australia

[ ]Nutrition Department, Alfred Health, Commercial Road, Melbourne, 3004 Australia

[ ]Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Park Road, Grafton, Auckland New Zealand

[ ]Intensive Care Unit, The Alfred Hospital, Commercial Road, Melbourne, 3004 Australia

[ ]Medical Research Institute of New Zealand, Wellington, New Zealand

[ ]Faculty of Medical and Health Sciences, University of Auckland, Park Road, Grafton, Auckland New Zealand

[ ]The Department of Critical Care Medicine, Auckland City Hospital, Park Road, Grafton, Auckland New Zealand

[ ]Nutrition and Dietetics, Auckland City Hospital, Park Road, Grafton, Auckland New Zealand

Article

Publisher ID: 1118

DOI: 10.1186/s13063-015-1118-y

PMC ID: 4690293

SO-VID: 7ffdaa45-f288-4f5b-919b-221de14bff23

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 : 3 August 2015

Date accepted : 14 December 2015

Funding

Funded by: FundRef http://dx.doi.org/http://dx.doi.org/10.13039/100007658, Baxter Healthcare Corporation (US);

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: clinical nutrition,nutrition therapy,enteral nutrition,parenteral nutrition,critical care,randomised controlled trials

Data availability:

ScienceOpen disciplines: Medicine

Keywords: clinical nutrition, nutrition therapy, enteral nutrition, parenteral nutrition, critical care, randomised controlled trials

Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial

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Abstract

Background

Methods/design

Discussion

Trial registration

Electronic supplementary material

Related collections

Herbal Medicines Journal (Herb Med J)

Most cited references 12

ESPEN Guidelines on Enteral Nutrition: Intensive care.

Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial.

Trial of the route of early nutritional support in critically ill adults.

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