Engel 1997.
Methods | RCT, single‐centre, 3‐arm, parallel design | |
Participants |
Number of randomized participants: 20 Inclusion criteria
Exclusion criteria
Primary diagnoses
Baseline characteristics EN group (standard)
EN group (supplemented)
PN group
Country: Germany Setting: ICU |
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Interventions |
EN group (standard) n = 10; 0 losses Details: nasojejunal tube with feeding pump, feeding started within 24 hours of trauma, "Oligopeptide standard diet" (Survimed OPD, Frensenius). Target energy of 25 kcal/kg/day. Initial rate of 25 mL/hour. Infusion rate increased at rate of 25 mL/hour up to the 4th day and a minimum of 75 mL/hour. Caloric intake received: not reported EN group (supplemented) n = 10; 0 losses Details: nasojejunal tube with feeding pump, feeding started within 24 hours of trauma. Formula consisted of Impact (Fa. Sandoz), supplemented with arginine, omega‐3 fatty acids, nucleotide, and selenium. Target energy of 25 kcal/kg/day. Initial rate of 25 mL/hour. Infusion rate increased at rate of 25 mL/hour up to the 4th day and a minimum of 75 mL/hour. Caloric intake received: not reported PN group n = 10; 0 losses Details: isocaloric and isonitrogenous total PN Caloric intake received: not reported |
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Outcomes |
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Notes |
Funding/declarations of interest: not reported Study dates: not reported Note: for the purpose of review analysis, we combined data for the 2 EN groups. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomized but no additional details |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No details and we assumed investigators made no attempts to blind personnel |
Blinding of outcome assessment (detection bias) All outcomes (except mortality) | Unclear risk | No details |
Blinding of outcome assessment (detection bias) Mortality | Low risk | No details. Lack of blinding unlikely to influence outcome data for mortality |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent losses |
Selective reporting (reporting bias) | Unclear risk | Clinical trials registration of prospectively published protocol not reported; not feasible to assess risk of reporting bias |
Baseline characteristics | Low risk | Appear comparable |
Other bias | Low risk | No other sources of bias identified |