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. 2012 May 16;2012(5):CD008344. doi: 10.1002/14651858.CD008344.pub2
Methods Randomised trial comparing two different parenteral nutrition solutions (standard or branched‐chain amino acids) to no parenteral nutrition in patients hospitalized for liver transplant. Geographical location Pittsburgh, Pennsylvania, USA. Study published 1999.
Participants Inclusion criteria: Immediately postoperative after successful liver transplantation. Exclusion criteria: None cited. 28 patients (13 men/15 women, mean age 49).
Interventions Intervention group received parenteral nutrition (1.5 gm/d standard or branched chain amino acids, 35 kcal/kg/d [carbohydrate and lipid]); Controls received standard dextrose solutions intravenously. Duration 7 days. All patients received cyclosporine and steroids.
Outcomes Mortality, serum bilirubin, duration intensive care unit and total hospitalization, cost, nitrogen balance
Category of study Parenteral nutrition/Surgical (liver transplant).
Sample size calculation None reported if done.
Full paper or abstract only Full paper.
Notes For bilirubin outcome, we used the calculated mean of two treatment groups and the lower standard deviation (since no significant difference between the two groups) and compared to the control group. Unable to find address or location for Dr Reilly; e‐mail sent to coauthor, Dr Leonard Makowka (Lmakowka@ITFGP.com) on September 13 failed; letter then sent by US mail (Leonard Makowka, M.D., ITF Global Partners. 181 Hudson Street, PH, New York, NY 10013). No response has been received as of March 20, 2012.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Only states "randomised".
Allocation concealment (selection bias) Unclear risk No details.
Blinding (performance bias and detection bias) All outcomes High risk Not blinded.
Incomplete outcome data (attrition bias) All outcomes Low risk No dropouts.
Selective reporting (reporting bias) High risk Serum bilirubin not useful, as patients had liver transplant as confounding factor; no postoperative morbidity reported, so no morbidity data at all reported.
Other bias Unclear risk Funding source not reported.
Intent to treat analysis Low risk No dropouts.
Baseline imbalance? Low risk No differences identified.
Early stopping? Unclear risk No sample size calculation and unknown why stopped.