Adams 1986.
Methods | RCT, single‐centre, 2‐arm, parallel design | |
Participants |
Total number of randomized participants: 46 Inclusion criteria
Exclusion criteria
Primary diagnoses
Baseline characteristics EN group
PN group
Country: USA Setting: medical centre |
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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 |
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Outcomes |
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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 |
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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 |