Elsevier

The Lancet

Volume 381, Issue 9864, 2–8 February 2013, Pages 385-393
The Lancet

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

https://doi.org/10.1016/S0140-6736(12)61351-8Get rights and content

Summary

Background

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.

Methods

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.

Findings

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).

Interpretation

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.

Funding

Foundation Nutrition 2000Plus, ICU Quality Funds, Baxter, and Fresenius Kabi.

Introduction

Nutritional support for patients in the intensive-care unit (ICU) is part of standard care. When the gastrointestinal tract is functioning, guidelines recommend early initiation of enteral nutrition (EN).1, 2, 3 However, findings have shown that EN alone frequently results in insufficient energy and protein intakes4 leading to underfeeding, which causes complications. Even in stable patients in the ICU, early initiation of EN is associated with a high incidence of gastrointestinal intolerance, and potentially serious adverse events, such as bronchoaspiration5 with an increased risk of pneumonia.6

Results of meta-analyses show that parenteral nutrition (PN) is not associated with excess mortality compared with EN.2, 7 However, the optimum timing of PN initiation is controversial. We previously proposed an algorithm using the supplemental PN (SPN) approach (EN combined with PN when EN alone is insufficient),8 which aims to optimise clinical outcome by providing patients with their full energy target from day 4 after admission to the ICU. However, the combination of PN with EN can cause overfeeding,9 leading to increased risk of infection, metabolic disturbances such as hyperglycaemia, liver dysfunction, and extended time on mechanical ventilation. Therefore both underfeeding and overfeeding carry risks of infectious complications and can delay weaning from mechanical ventilation.

We aimed to test the hypothesis that individually optimised energy provision by SPN for 5 days after day 3 of ICU admission could improve clinical outcome in severely ill patients in the ICU for whom EN alone is insufficient.

Section snippets

Trial design and patients

This two-centre, randomised, controlled, intervention trial took place in the mixed medical and surgical ICUs of two tertiary care hospitals in Switzerland: Geneva University Hospital and Lausanne University Hospital. After trial approval by both institutional ethics committees, we recruited adult patients 3 days after they had been admitted to the ICU. Written informed consent was obtained from the patients or their next of kin. Eligible patients were those who had received less than 60% of

Results

We enrolled 305 patients between December, 2008, and December, 2010, 153 of whom were assigned to receive SPN, and 152 to EN only. All patients received their allocated nutritional protocol, although 20 in the SPN group and ten in the EN group discontinued the study, mostly because of protocol violation (figure 2).

Demographic and clinical characteristics of the trial groups were similar at randomisation (table 1). On day 4, the mean cumulative deficit of all patients was −3999 kcal (SD 1293) on

Discussion

Findings from this trial suggest the clinical usefulness of complementing the energy delivery of insufficient EN with a parenteral booster between day 4 and day 8 after ICU admission. The provision of close to 100% of energy requirements reduced the risk of development of nosocomial infections, the number of antibiotic days, and the duration of mechanical ventilation in patients without nosocomial infections up to day 28.

This trial is one of the first studies to show that a combined feeding

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