Young 1987.
Methods | RCT, single‐centre, 2‐arm, parallel design | |
Participants |
Total number of randomized participants: 51 Inclusion criteria
Exclusion criteria
Primary diagnosis
Baseline characteristics EN group
PN group
Country: USA Setting: medical centre |
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Interventions |
EN group n = 28; some early participant loss but study authors do not report to which group these participants belonged. 11 participants did not tolerate tube feedings and were switched to PN group; used ITT analysis Details: nasogastric tube feeding, started as soon as feeding tube in place. Feeding assumed to be for duration of study (i.e. 18 days). Target rate of delivery set at 1.75 x Harris Benedict BEE and 1.5 g protein/kg bodyweight/day. Formula consisted of Traumacal (1.5 calories/mL and 22% protein, 40% fat, and 38% carbohydrate) or Ensure Plus (1.5 calories/mL and 14.7% protein, 32% fat, and 53.3% carbohydrate). Participants given metoclopramide 10 mg/6 hours to stimulate gastrointestinal motility. No participant was treated with corticosteroids Cumulative intake of protein, mean (SEM): 1.35 (± 0.12) g/kg/day PN group n = 23; some early participant loss but study authors did not report to which group these participants belonged; use of ITT analysis Details: feeding commenced within 48 hours of randomization. Feeding assumed to be for duration of study (18 days); however, participants were given EN once bowel sounds were present and GRV < 100 mL every 2 hours. Target rate of delivery set at 1.75 x Harris Benedict BEE and 1.5 g protein/kg bodyweight/day. Formula consisted of sterile AA/dextrose solutions, multi‐vitamins, trace elements, and IV lipids. 17% calories as protein, 41% as fat, 42% dextrose. No participant was treated with corticosteroids Cumulative intake of protein, mean (SEM): 0.91 (± 0.09) g/kg/day |
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Outcomes |
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Notes |
Funding/declarations of interest: not reported Study dates: not reported Note: we assumed that study participants were in the ICU, although study authors did not report this in the paper. |
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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 that there were 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 | Lack of blinding unlikely to influence outcome data for mortality |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 7 participants were entered into the study but due to exclusion criteria were excluded from analysis, included 5 deaths within 4 days. Study authors did not report to which group these participants belonged |
Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or prospectively prepared protocol not reported; not feasible to assess risk of reporting bias |
Baseline characteristics | Low risk | Appeared comparable |
Other bias | Unclear risk | Participants in PN group received more calories until the 9th day of study, and 11 EN participants required PN |
AA: amino acid; ACCP: American College of Chest Physicians; ADL: activities of daily living; APACHE II: Acute Physiology and Chromic Health Evaluation II; ARDS: acute respiratory deficiency syndrome; ASA: American Society of Anesthesiologists; ATI: Abdominal Trauma Index; BEE: basal energy expenditure; BMI: body mass index; COPD: chronic obstructive pulmonary disease; CT: computed tomography; DNR: do not resuscitate; EN: enteral nutrition; F: female; GCS: Glasgow Coma Scale; GRV: gastric residual volume; HCN: high calorie nutrition; ICU: intensive care unit; iEN: immuno‐enteral nutrition; ISS: Injury Severity Score; ITT: intention‐to‐treat; IQR: interquartile range; IV: intravenous; LOS: length of stay; M: male; n: number of participants; NICU: neuro‐intensive care unit; NIHR: National Institute of Health Research; NPC: non‐protein calorie; NRS: nutritional risk score; PN: parenteral nutrition; RCT: randomized controlled trial; RIFLE: scoring system for acute kidney injury, risk, injury, failure, loss, end‐stage renal disease; SAPS: Simplified Acute Physiology Score; SCCM: Society of Critical Care Medicine; SD: standard deviation; SF‐36: 36‐item Short Form; SEM: standard error of the mean; SIRS: systemic inflammatory response syndrome; SOFA: Sequential Organ Failure Assessment; TBI: traumatic brain injury; TEN: total enteral nutrition; TPN: total parenteral nutrition; VAP: ventilator‐acquired pneumonia; WBC: white blood cell.