Bauer 2000.
Methods | Randomised clinical trial (blocks of 10), France | |
Participants | 120 hospitalised adults admitted to the ICU for more than 2 days, at nutritional risk due to being in the ICU Male:Female = 82:38 Mean age: 54 years Exclusion criteria: elective surgery or presenting a contraindication to enteral or parenteral support, or both, having a previous history of allergy to vitamins |
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Interventions | Experimental group: received parenteral nutrition. Treatment consisted of a 3‐in‐1 solution of carbohydrates, fat, and protein, Vitrimix KV and hydrosoluble vitamins, Soluvit. (n = 60)Control group: received placebo. Treatment consisted of sodium chloride 0.9% with Intralipid 20% (50 ml/l) and Soluvit (10 ml/l), stable for 24 hrs Treatment and placebo were administered in the same type of plastic bags (1 ± 2 l), at a concentration of 1 kcal/ml in the treatment group. The solution was administered through a central line (960 mOSm/l) that was not inserted solely for nutritional purposes. The rate of intravenous administration was increased to 120 ml/hr for 18 ± 24 hrs. (n = 60) Co‐intervention: both groups received enteral support: Participants were bolus‐fed every 4 hrs, 5 times a day with a standard, noncommercial, modular polymeric diet. The composition of the solution was protein (20%), polyunsaturated fats (30%), carbohydrates (50%), non‐soluble fibres, sodium chloride (2 g/l), potassium chloride (3 g/l), and a standard solution of hydro‐ and lipo‐soluble vitamins; the concentration of the solution was 1 kcal/ml. A typical 70‐kg participant would receive 100 ml initially, with an increased amount in 50‐ml steps to a maximum of 350 ml every 4 hrs 5 times a day. |
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Outcomes | Levels of retinol‐binding protein and prealbumin, morbidity, mortality, cost | |
Study dates | Not stated | |
Notes | No contact information could be obtained. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | The envelopes were described as sealed but it was uncertain if the envelopes were opaque. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Neither the healthcare providers nor the participants were aware of the treatment given. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Although the statistician was blinded to the allocation of treatment until all events had occurred, it is not stated clearly who performed the outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 6/60 early dropouts in the experimental group and 7/60 in the control group They stated that they used intention‐to‐treat analysis, but did not fully describe how they dealt with missing participants. |
Selective reporting (reporting bias) | Low risk | The trial reported all‐cause mortality and serious adverse events. No protocol could be found. |
For‐profit bias | Unclear risk | It was unclear how the trial was funded. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |