Ahrens 2005.
Methods |
Study design: prospective, randomized controlled trial. Study dates: “study dates not available" Setting: level‐1 trauma centre. Department of Surgery, Detroit Receiving Hospital, Wayne State University, Detroit, Michigan Country: USA |
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Participants |
Inclusion criteria
Exclusion criteria
Sample size: calculated sample size of 26 participants to detect an absolute difference in glucose area under the curve of 50 mg hr/dl with 80% power (P = 0.05). 40 participants were randomized: 20 to each group. Only 18 were ICU participants (8 of the low caloric and 10 of the standard group). At baseline both groups were well matched, with exception of lower creatinine clearance in the standard group. Age (years mean ± SD) group 1: 45.3 ± 17.2; group 2: 53.1 ± 17.9 Sex (male, %) group 1: 75; group 2: 80 Most frequent admitting diagnosis (groups 1 and 2 respectively): pancreatitis 6 & 6, trauma 7 & 3, bowel obstruction 4 & 5. ICU participants (n). group 1: 8; S group 2: 10 APACHE II score (mean ± SD of participants in ICU). Group 1: 20.1 ± 9.1; Group 2: 18.6 ± 11.1 Mechanical ventilation (n). 8 participants in each group Baseline nutrition status No major differences between ideal and actual body weight in both groups Duration of parenteral nutrition (days; median (interquartile range)). group 1 6 (4 to 10); group 2 7 (5 to 10) |
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Interventions |
Group 1, low caloric parenteral nutrition (n = 20)
Group 2, standard parenteral nutrition (n = 20)
In both groups, parenteral nutrition was administered by a multiple‐bottle system. Lipids administration was standardized to 1000 kcal 3 times weekly. Proteins administered according the levels of estimated metabolic stress of the disease (mild 1.2 ‐ 1.4; moderate 1.5 ‐ 1.7; or severe 1.8 ‐ 2.2 gr/kg/day) |
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Outcomes |
Primary outcomes
Incidence of hyperglycaemia was calculated as the number of assessments of glycaemia ≥ 200 mg/dl divided by the total number of assessments Severity of hyperglycaemia was assessed by measuring the area under the curve Secondary outcomes
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Funding sources | Not available | |
Declarations of interest | The authors have no financial interests to disclose | |
Notes | Total calories administered/kg (median (interquartile range)) were: 26.6 (26.2 to 27.5) and 37.0 (36.6 to 38.4); the amount of protein administered and the duration of PN therapy were similar. The first author sent the data of continuous outcomes expressed as mean and standard deviation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomly assigned by means of a computer‐generated random‐numbers |
Allocation concealment (selection bias) | Low risk | Central allocation (pharmacist) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Clinicians were blinded to which caloric group participants were randomized to, with the exception of the critical care pharmacist who calculated the formula. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Clinicians were blinded to which caloric group participants were randomized to, with the exception of the critical care pharmacist who calculated the formula. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes: outcome data were available for all participants. |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No evidence of other bias |