Liver transplantation for liver cirrhosis Digestive System Liver transplantation for liver cirrhosis
Conditions
Interventions
Participants immediately post liver transplant will be randomised on admission to the intensive care unit to one of two treatment groups for the first 12 hours.
Intervention group: Participants under
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 80 years 2. Liver cirrhosis 3. Selected to undergo liver transplantation 4. Competent to give consent
Exclusion criteria
Exclusion criteria: 1. Non-cirrhotic liver disease 2. Pregnancy 3. Age less than 18 years or over 80 years 4. Body weight less than 40 kg 5. Re-transplantation for primary graft non-function 6. Fulminant hepatic failure 7. Emergency surgery 8. Known learning disabilities or previously lacking capacity to consent for themselves 9. Prisoners 10. Patients already enrolled in an interventional study 11. Refusal or inability to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility is determined at the end of the study period as the: 1. Ability to recruit patients at the site: A recruitment rate of greater than 40% of patients fulfilling the criteria for this study will be deemed as successful 2. Rate of withdrawal from GDFT protocol: A withdrawal rate of less than 10% will be deemed as successful 3. Reasons for withdrawal from GDFT protocol: Qualitatively assessed 4. Ability to adhere to the GDFT protocol for the 12 hour intervention period: Less than 10% of patients with a deviation from the protocol will indicate success | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life is measured using Eq5D pre-transplant, 3 and 6 months 2. Postoperative complications are measured using the Clavien-Dindo Classification of surgical complications at 6 months 3. Hospital length of stay is measured using hospital computer system in days 4. ICU length of stay is measured using using hospital computer system in days 5. Graft (liver) function and survival is measured at 6 months by monitoring postoperative complications specifically related to liver transplantation surgery, occurring within 180 days of liver transplantation, defined as any of the following: 5.1. Two or more episodes of graft rejection (biopsy proven and treated) 5.2. Vascular thrombotic episodes 5.3. Bleeding requiring intervention 5.4. Acute kidney injury requiring renal replacement therapy 5.5. Biliary leak requiring intervention 5.6. Biliary stricture requiring intervention 5.7. Cytomegalovirus, fungal or bacterial infection at any site confirmed by culture 6. Patient survival is measured using hospital information system at 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed