Methods |
Randomised trial comparing two different parenteral nutrition solutions (a standard one and one containing glutamine) to a control group receiving no nutritional interventions in patients undergoing liver transplantation. |
Participants |
Patients undergoing liver transplantation. |
Interventions |
One interventional group received standard parenteral nutrition (1 gm/kg amino acids as a commercial BCAA solution, 104.5 kJ/kg [dextrose and MCT/LCT combination 20% solution in a 2:1 ratio of carbohydrate to fat]) and a second intervention group receiving an isocaloric, isonitrogenous solution containing glutamine. Treatment was provided for 7 days postoperatively. The control arm received only standard intravenous fluids (5% dextrose and minerals). |
Outcomes |
Mortality (both short term and long term), duration of hospitalization, a variety of lab tests (including parameters of the Prognostic Nutritional Index). |
Category of study |
Parenteral nutrition, Surgical. |
Sample size calculation |
None reported. |
Full paper or abstract only |
Full paper. |
Notes |
For purposes of this analysis, the short‐term mortality was employed (since this was a surgical trial and the therapy was all done during that hospitalization). Both treatment groups were combined and compared to the control arm. 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. Attempt to send e‐mails to both Dr Qiu (Yudongqui510@hotmail.com and Yudongqiu510@hotmail.com) and Dr Ding (yitaoding@hotmail.com) on September 13/14, 2011 failed; both returned. Letter sent to Dr Ding on September 14, 2011 (Dr Yitao Ding, Department of Hepatobiliary Surgery, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Zhongshang Road 321, Nanjing 210008, China). 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 stated that the patients were "randomly assigned". |
Allocation concealment (selection bias) |
Unclear risk |
No details provided. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk |
No placebo intravenous solution provided, although it was stated that the two treatment arms could not be distinguished. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
No apparent dropouts (One patient excluded for graft dysfunction, but it was assumed that that was the reason for the liver transplantation that was responsible for the patient being considered for the trial.) |
Selective reporting (reporting bias) |
High risk |
No hepatic or postoperative morbidity data provided. |
Other bias |
Unclear risk |
Funding source not disclosed. |
Intent to treat analysis |
Low risk |
No dropouts. |
Baseline imbalance? |
Low risk |
No differences in the baseline features. |
Early stopping? |
Unclear risk |
No explanation provided regarding why the trial was stopped when it was. |