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. 2018 Jun 8;2018(6):CD012276. doi: 10.1002/14651858.CD012276.pub2

Adams 1986.

Methods RCT, single‐centre, 2‐arm, parallel design
Participants Total number of randomized participants: 46
Inclusion criteria
  1. 18 to 60 years of age

  2. 80% to 130% of desirable bodyweight

  3. Significant injuries to ≥ 2 body systems


Exclusion criteria
  1. History of hepatic or renal failure


Primary diagnoses
  1. People with trauma injuries to include: head injury, spinal fracture, severe facial fractures, severe thoracic injury, major intra‐abdominal injury, pelvic fracture, long bone fractures, or other major soft‐tissue injury


Baseline characteristics
EN group
  1. Age, mean (SD): 30 (± 9) years

  2. Gender M/F: 15/8

  3. APACHE II: not reported


PN group
  1. Age, mean (SD): 29 (± 10) years

  2. Gender M/F: 16/7

  3. APACHE II: not reported


Country: USA
Setting: medical centre
Interventions EN group
n = 23; 0 losses; 4 participants required conversion to PN; assume ITT analysis
Details: jejunostomy tube placement. Feeding started on first postoperative day. Feeding assumed to be for duration of study period (14 days). Target rate changed during study as participants in both groups appeared to have insufficient nitrogen balance; Phase 1: target rate calculated as Harris‐Benedict BEE x 1.68, Phase 2: target rate calculated as Harris‐Benedict BEE x 2.0 plus an additional 20%. Formula consisted of polymeric feeding solution (5 participants received Isocal HCN: 15% protein calories, 45% carbohydrate calories, 49% lipid calories. 18 participants received Traumacal: 22% protein calories, 40% carbohydrate calories, 48% lipid calories) (Mead Johnson Nutritional Division, Evansville, IN, USA). Participants given insulin to manage blood glucose levels. Metabolic or gastrointestinal intolerances were treated by physician as required.
Caloric intake received, mean: Phase 1: 2088 calories; Phase 2: 2678 calories
PN group
n = 23; 0 losses
Details: subclavian line placement. Feeding started on first postoperative day, assumed duration of study period (14 days). Phase 1: target rate calculated as Harris‐Benedict BEE x 1.68, Phase 2: target rate calculated as Harris‐Benedict BEE x 2.0. Formula consisted of 25% dextrose, 4.25% crystalline AAs (Travasol: Baxter Healthcare Corporation, Deerfield, IL, USA). Additional caloric prescriptions of 500 mL of 10% lipid, twice weekly, were optional. 50 mL per hour for first 24 hours, then advanced as tolerated at physician's discretion.
Caloric intake received, mean: Phase I: 2572 calories; Phase 2: 2876
Outcomes
  1. Length of hospital stay

  2. Length of ICU stay

  3. Length of time on the surgical service

  4. Number of ventilator days

  5. Number and type of operations

  6. Total number of days receiving EN or PN

  7. First day of oral intake

  8. Weight at time nutritional support was discontinued

  9. Medical complications (wound infection, pneumonia, intra‐abdominal infection, persistent fever, gastrointestinal bleeding, hepatic failure, acute renal failure, pancreatitis)

  10. Complications (bloating, cramps, nausea; diarrhoea (diagnosed by 3 to 6 loose or liquid stools per day, or > 6 loose stools for severe diarrhoea)

  11. Catheter sepsis (not clearly reported)

  12. Mortality

  13. Costs of nutritional support

Notes Funding/declarations of interest: supported, in part, by a grant from Mead Johnson Nutritional Division, Evansville, IN, USA
Study dates: January 1982 to June 1984
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomized by surgical team in operating theatre. No additional information provided
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 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 evidence of blinding. 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 trial registration or prospectively written protocol not reported. Not feasible to judge selective outcome reporting bias
Baseline characteristics Low risk Appeared comparable
Other bias Unclear risk Changes to feeding protocol during study, but target rates were comparable between groups. No other sources of bias identified