Intraoperative hemodynamic management and postoperative outcomes in liver transplantation: a multicenter prospective cohort study
Liver transplantation improves the survival of end-stage liver disease patients. However, severe postoperative complications are frequent and how to optimise the intraoperative management is based solely on expert opinion. Intraoperative hemodynamic management is a modifiable component of perioperative care that likely influences postoperative outcomes as suggested by data from other surgical populations and our preliminary work. In particular, intravenous fluid management seems to be associated with postoperative complications and survival.
We will conduct a multicenter prospective observational cohort study to assess the potential effects of intraoperative hemodynamic management on postoperative outcomes in liver transplantation and inform the design of a future multicentre perioperative clinical trial in this population. The specific objectives of this study are to measure the association between the intraoperative hemodynamic management and postoperative complications and mortality and to measure the incidence of such complications in Canada.
We will include all consecutive adults undergoing a liver transplantation in five Canadian centers (CHUM, MUHC, TGH, LHSC, UAH) and one French center (Paul-Brousse Hospital) during a one-year period anywhere between June 2021 and November 2022 and follow patients up to 6 months. We will measure the association between intraoperative fluid balance and postoperative complications. We plan to include around 450 liver transplantations. Our primary outcome will be primary graft dysfunction at 7 days. Our secondary outcome will be non-anastomotic biliary complications up to 6 months after transplantation. Our other secondary outcomes will include biliary anastomotic strictures and retransplantation up to 6 months, liver transplant-related reoperations up to 30 days, AKI at 48 hours, 7 days and 30 days, pulmonary complications (pulmonary edema and acute respiratory distress syndrome (ARDS)) and infectious complications up to 30 days, 30-day mechanical ventilation and ICU free days, hospital length of stay as well as hospital readmissions, graft survival, acute rejection episode and mortality up to 6 months. We will first describe the incidence of postoperative complications after liver transplantation in Canada. We will then analyse their association with intraoperative hemodynamic management. Our analyses will use fluid balance as a main exposure variable and will be adjusted for the intraoperative dose of vasopressors used and the importance of the residual intraoperative hypotension, as well as other potential baseline confounders of the association between fluid management and postoperative complications. Our primary analysis will be a time-to-event analyse with a random effect to take into account inter-center variability.
This study will inform the design of a future trial that may change practice. It will help develop a collaborative research network around the perioperative care of liver transplant recipients that will make such a future trial possible. These fragile patients need perioperative interventions supported by high-quality data that may improve graft survival and postoperative outcomes so their transplantation opportunity will tranform into a cure and improve their quality of life.