Optimising the cardiovascular system following liver transplantation surgery

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: 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 undergo goal directed fluid therapy (GDFT) for 12 hours post‐operatively. This involves the used of a FloTrac cardiac output monitor (EV1000 Clinical Platform, Edwards Lifesciences, Irvine, USA) to measure stroke volume, which will be used to determine IV fluid administration. The Edwards EV1000 cardiac output monitor is a non‐invasive pulse wave contour analysis device that calculates cardiac output and stroke volume. Electronic information from the indwelling arterial catheter that all of these patients have inserted as part of their routine treatment is sent to the EV1000 to calculate cardiac output and stroke volume. Control group: Participants are treated using the standard current management of IV fluids for 12 hours post‐operatively. Participants in both study arms are followed up after six months CONDITION: Liver transplantation for liver cirrhosis ; Digestive System ; Liver transplantation for liver cirrhosis PRIMARY OUTCOME: 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 OUTCOME: 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 INCLUSION CRITERIA: 1. Aged between 18 and 80 years 2. Liver cirrhosis 3. Selected to undergo liver transplantation 4. Competent to give consent
Epistemonikos ID: fa363c970ea58dada8f38a513012b776a2a651a2
First added on: Aug 24, 2024