Hasse 1995.
Methods | Randomised clinical trial, USA | |
Participants | 50 hospitalised adults undergoing surgery with liver transplant, at nutritional risk due to major surgery Male:Female = 17:14 (completed the study) Mean age = 51 years Exclusion criteria: Dialysis requirements or choledochojejunostomy was performed at the time of transplant. |
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Interventions | Experimental group: With feeding‐tube the participants were given full‐strength Reabilan HN (Elan Pharma, Cambridge, MA) 12 hours after surgery. The infusion rate was started at 20 ml/hr and was increased to 40 mL/hr 24 hrs after the initiation of the tube‐feeding. If tolerated 40 mL/hour, the feeding rate was increased to 60 mL/hr 12 hrs after the previous rate increased.(n = 25) Control group: Conventional IV electrolytes(n = 25) Co‐interventions: non‐feeding naso‐gastric tube |
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Outcomes | Medical condition, tube‐feeding tolerance, signs of infection, calorie and protein intake, resting energy expenditure, respiratory quotient (RQ), urinary urea nitrogen (UUN), nitrogen balance, hand‐grip strength, length of hospital stay, rehospitalisation, overall cost, weight, chemical assays | |
Study dates | Not stated | |
Notes | We contacted the authors on 19th August 2015 by email: jm.hasse@baylorhealth.edu . We received no reply. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | The 2 groups could not be described as similar, and the dropout rate was above 5%. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained, and the trial did not report all‐cause mortality. |
For‐profit bias | High risk | The study was supported in part by grants from the Di‐etitians in Nutrition Support Practice Group Member Research Award, Elan Pharma. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |