None listed
Conditions
Brief summary
Malnutrition is a common problem in patients waiting for a liver transplant and can impact their health both before and after transplantation. Malnutrition prior to transplant can be caused by poor dietary intake due to the symptoms of chronic liver disease, altered metabolism of nutrients, or malabsorption. Poor nutritional status can be identified by weight loss, muscle wasting, poor appetite, and/or blood tests. Patients with malnutrition who are waiting for liver transplant are encouraged to eat a high calorie and protein diet with additional supplement drinks, to help meet their extra nutritional needs. However, most patients are not able to consume enough of their usual meals and extra supplements to meet these needs, which can worsen malnutrition and influence recovery after surgery. Many studies have shown that malnourished patients undergoing liver transplant have a longer hospital length of stay, have an increased number of infections, increased incidence of rejection, and are more likely to be readmitted to hospital in the early months after transplant. Patients with malnutrition awaiting liver transplant who aren’t able to eat or drink enough may therefore need a different way to meet their nutrition needs. Enteral nutrition (nutrition fed by a ‘nasogastric’ tube (NGT) directly into the stomach) is the preferred way for these patients to receive all the energy, protein and nutrition they need, and can be undertaken in both hospital and at home. The aim of this study is to determine if NGT feeding before liver transplant helps improve outcomes for patients with malnutrition. Patients will be randomised to either NGT feeding while awaiting transplant, or standard high energy and protein diet (current practice). Patients in the NGT group will have a NG feeding tube inserted and receive feeds overnight to meet 75% of their nutrition needs. They will also be allowed to eat and drink throughout the day (to meet the other 25%). Patients in the diet group will be advised by the dietitian to eat high energy and protein foods and fluids (target 100%), which is the current standard practice for patients before liver transplant. If NG feeding is effective, it may minimise the loss of weight and muscle strength that commonly occurs before transplant; and has the potential to reduce patient length of stay, and reduce episodes of infection and rejection after transplant.
Interventions
Nasogastric feeding with Isosource 2.0 (energy-dense polymeric complete enteral formula) for eligible malnourished patients awaiting liver transplant.
Nasogastric feeds will be administered overnight to provide 75% of the patient's energy requirements, with oral diet making up the remaining 25%.
The duration of nasogastric feeding will be for the length of time the patient is on transplant waiting list (typically 1-5 months).
Patient compliance will be monitored by regularity of enteral feed ord
Nasogastric feeding with Isosource 2.0 (energy-dense polymeric complete enteral formula) for eligible malnourished patients awaiting liver transplant. Nasogastric feeds will be administered overnight to provide 75% of the patient's energy requirements, with oral diet making up the remaining 25%. The duration of nasogastric feeding will be for the length of time the patient is on transplant waiting list (typically 1-5 months). Patient compliance will be monitored by regularity of enteral feed ordering and enteral feed return (at monthly review).
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All adult patients activated onto the liver transplant waiting list with: - Diagnosis of severe malnutrition (SGA C) - Handgrip strength below the sarcopenia cut-off for their age/sex - Functional gastrointestinal tract - MELD score >16
Exclusion criteria
Participants on the liver transplant waiting list will be excluded if they: - Are well nourished (SGA A) or mild-moderately malnourished (SGA B) - Are not sarcopenic as per handgrip strength cut off - Without functioning gastrointestinal tract - Have a low severity of liver disease (MELD <16)
Outcome results
None listed