Methods |
Randomised trial comparing enteral nutrition to no enteral nutrition in patients hospitalized awaiting liver transplant. Geographical location: New York, New York, USA. Abstract published 1995. |
Participants |
Inclusion criteria: Hospitalized patients awaiting liver transplantation > 18 years. Exclusion criteria: Hospitalized in ICU, grade 4 hepatic encephalopathy, infections precluding transplantation. 42 hospitalized patients (no data regarding sex or age; 10 dropped out). |
Interventions |
Intervention group received enteral nutrition through nasogastric tube (Commercial formulation [Impact®]) + unrestricted oral diet prior to transplant; Control group given unrestricted oral diet. Mean duration of therapy at least 5 days (excluded if fewer days). |
Outcomes |
Hepatic encephalopathy. |
Category of study |
Enteral nutrition/Medical. |
Sample size calculation |
Not reported if done. |
Full paper or abstract only |
Abstract. |
Notes |
Randomised patients who received transplant within 5 days were excluded from analysis. Data obtained from author at poster. Request for further information sent via US mail on September 16, 2011 to senior author, Dr Miller, as Dr Guy could not be located. (Charles Miller, MD, Transplantation Center, Director, Cleveland Clinic Main Campus, Mail Code A80, 9500 Euclid Avenue, Cleveland, OH 44195). Dr Miller responded on September 24, 2011; he had no information but suggested that we try to contact Dr Steve Guy at Hahneman. A search for a Dr Stephen Guy turned up the following address: Stephen Guy, MD, Drexel Transplant Associates, 216 N. Broad Street, Feinstein Building, 5th Floor, Philadelphia, PA 19102 and letter sent to him on September 26, 2011. 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 "prospective randomised trial". |
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 |
High risk |
10 dropouts (unknown how many from each group nor reasons for all of them, although at least some probably had transplant within 5 days of randomisation). |
Selective reporting (reporting bias) |
High risk |
No mortality data provided. |
Other bias |
Unclear risk |
Funding source not identified. |
Intent to treat analysis |
High risk |
Could not be done. |
Baseline imbalance? |
Low risk |
Although no numbers were presented, poster stated that there were no differences. |
Early stopping? |
Unclear risk |
No sample size calculation and unknown why stopped. |