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 |
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Participants |
Inclusion criteria
Exclusion criteria
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 |
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Interventions |
Permisive underfeeding group (n = not available )
Standar protocol feeding group (n = not available)
Same protein intake for both groups: 1.5 gr protein/kg/day Each participant monitored for 14 days |
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Outcomes |
Primary outcome
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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