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. 2018 Jun 4;2018(6):CD007867. doi: 10.1002/14651858.CD007867.pub2

Charles 2014.

Methods Study design: prospective, randomized controlled trial
Study dates: March 2008 to November 2011
Setting: Surgical/trauma ICU at a tertiary‐care hospital. Department of Surgery, University of Virginia Health System. Charlottesville, Virginia
Country: USA
Participants Inclusion criteria

  1. Age ≥ 18 years; projected need for nutrition support > 48 hrs and for ICU stay > 48 hrs according to the attending intensivist


Exclusion criteria

  1. Participants aged < 18 years, expected to die or ICU discharge within 48 hours, pregnancy and primary diagnosis of burn


Sample size: From 2892 admissions to the ICU 83 participants were enrolled and randomized: 41 to the hypocaloric group and 42 to the eucaloric group (detailed flow diagram given of the randomization, exclusion and study end)
Age (years; mean ± SD). Hypocaloric group 50.4 ± 2.8; Eucaloric group 53.4 ± 2.7
Sex (male, %). Group 1: 58.3; Group 2: 73.8
Primary disease. Trauma admission (%). Group 1: 68.3; Group 2: 59.5. The other participants in the surgical ICU were abdominal, vascular, orthopaedic and liver transplant surgery.
Disease severity, APACHE II score (mean ± SD) Group 1: 16.6 ± 0.9; Group 2: 17.3 ± 0.8
Mechanical‐ventilation dependence (%). Group 1: 68.3; Group 2: 57.1
Comorbidities. Diabetes mellitus and coronary artery disease (%). Group 1. 19.5 and 17.1 respectively; Group 2: 14.3 and 11.9 respectively
Nutrition status BMI (kg/m2, mean ± SD). Group 1: 32.9 ± 2.0; Group 2: 28.1 ± 0.9
Risk of refeeding syndrome at admission (due to weigh loss, poor caloric intake or alcohol abuse) (%). Group 1: 31.7; Group 2: 54.8
Level of inflammation: not available
Interventions Group 1 hypocaloric (n = 41)

  1. The hypocaloric target was 50% of the calculated daily caloric requirement: 12.5 to 15 kcal/kg actual weight/day


Group 2 eucaloric (n = 42)

  1. The goal was 100% of the calculated caloric requirements: 25 to 30 kcal/kg actual weight/day


Co‐interventions: the protein goal of the 2 groups was 1.5 grams protein/kg/day. If the participant’s actual weight was > 130% of ideal weight, adjusted weight was used. Participants with severe malnutrition not able to receive enteral nutrition were considered for parenteral nutrition, all others received enteral nutrition. In cases of enteral feeding intolerance, parenteral nutrition was started after 5 to 7 days.
Outcomes Primary outcome

  1. Development of hospital‐acquired infectious complications. The diagnosis of all the infections was done according to the criteria of US Centers for Disease Control and Prevention.


Secondary outcomes

  1. Glucose control during the study period: mean overall glucose values, mean morning glycaemia at 06.00 hours and mean daily insulin requirements

  2. Length of stay in ICU

  3. Length of stay in hospital

  4. Hospital mortality: all causes of in‐hospital mortality

  5. The study protocol was followed during 10 to 12 days

  6. The analysis of participants was done on an intention‐to‐treat basis


Subgroups

  1. The authors analysed but did not report subgroups of trauma and non‐trauma participants, and men versus women
Funding sources Supported by grant 5‐T32‐AI‐078875‐03 from the National Institute of Health, USA
Declarations of interest The authors stated that “No conflicts of interest were reported”
Notes Due to slow enrolment, the study was closed before the planned enrolment of 116 participants.
Enteral nutrition was given initially. Participants were considered for parenteral nutrition if they were severely malnourished and could not receive enteral feeding, or in case of continuous intolerance of enteral nutrition lasting more than 5 to 7 days.
The author provided additional information: mean and standard deviation of the length of mechanical ventilation and to complete the 'Risk of bias' table.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly allocated 1:1 by using a computer‐based random number generator
Allocation concealment (selection bias) Low risk Quote: "investigators were blinded to the preparation of the randomization envelopes, and the randomization assignment was determined by opening sequential opaque security envelopes containing the randomization assignment."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk There was no blinding of participants or personnel.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessment was blinded (written information provided by the author).
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All outcomes: outcome data were available for all participants.
Selective reporting (reporting bias) Low risk The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were prespecified.
Other bias Low risk No evidence of other bias