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

Theodorakopoulou 2016.

Methods Study design: prospective, randomized controlled trial
Study dates: period of one year, but study dates not available
Setting: single centre. ICU at Attikon University Hospital. Athens. Greece
Participants Inclusion criteria
  1. Mechanically‐ventilated septic participants


Exclusion criteria
  1. Obese patients


Sample size
Total number of participants enrolled: 74
Age (years): whole group age of 68.4 ± 18.4 years
Sex (male, %): 38 men included (100%)
Primary disease of the participants: all participants met the consensus criteria for sepsis.
Disease severity score: at entry overall APACHE II score 22 ± 4. etc. and SOFA score 8 ± 4
Mechanical ventilation: 100% of the participants were mechanically ventilated
Comorbidities: not reported
Nutrition status: non‐obese participants. Overall BMI ≈ 21.5 ± 3.4 kg/m2
Interventions Permisive underfeeding group (n = not available )
  1. Caloric goal 50% to 70% of calculated caloric requirements. During the study period the participants received 962 ± 314 kcal/day or 51 ± 14% of the caloric requirements, and 57 ± 24 grams protein day.


Standar protocol feeding group (n = not available)
  1. 80% to 100% of calculated caloric requirement. During the study period the participants received 1308 ± 513 kcal/day or 82 ± 14% of the caloric requirements, and 59 ± 25 grams of protein day.


Same protein intake for both groups: 1.5 gr protein/kg/day
Each participant monitored for 14 days
Outcomes Primary outcome
  1. 28‐day mortality

Funding sources Not available.
Declarations of interest Not available
Notes This information was extracted from an abstract. We contacted Dr. Maria Theodorakoupoulou to request the missing data (including outcome data).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information for judgement (abstract only)
Allocation concealment (selection bias) Unclear risk Insufficient information for judgement (abstract only)
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information for judgement (abstract only)
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information for judgement (abstract only)
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information for judgement (abstract only)
Selective reporting (reporting bias) Unclear risk Insufficient information for judgement (abstract only)
Other bias Unclear risk Insufficient information for judgement (abstract only)

Abbreviations:

APACHE = acute physiology and chronic health evaluation; BMI = Body Mass Index ; CD = cluster of differentiation; CIT = conventional insulin therapy; dl = decilitre; EN = enteral nutrition; gr = gram; GRV = gastric residual volumes; hr = hour; ICU = intensive care unit; IIT = intensive insulin therapy; IVFE = Intravenous fat emulsion; kcal = kilocalories; kg = kilograms; mg = milligrams; NHLBI = National Heart, Lung, and Blood Institute; NNIS = National Nosocomial Infection Surveillance; OMEGA = OMEGA study (Rauch 2010); PN = parenteral nutrition; SD = standard deviation; SOFA = sequential organ failure assessment; TPN = total parenteral nutrition; UAB = unassisted breathing; VFD = ventilator‐free days