Postoperative Supplemental Oxygen in Liver Transplantation (PSOLT)

The aim of this prospective randomized controlled trial is to evaluate the impact of high concentration supplemental postoperative oxygen therapy on short-term and long-term results of liver transplantation, particularly with respect to infections and biliary complications.

The aim of this prospective randomized controlled trial is to evaluate the impact of high concentration supplemental postoperative oxygen therapy on short-term and long-term results of liver transplantation, particularly with respect to infections and biliary complications. A total of 296 patients immediately after liver transplantation will be randomly assigned to receive either 80% (high concentration) or 28% (controls) fraction of inspired oxygen for 6 hours after surgery with a 1:1 allocation ratio. Patients will be blinded to the type of received intervention. Randomization will be stratified by the Child-Turcotte-Pugh classification. Both groups will be compared to short- and long-term outcome measures.

liver transplantation, postoperative infection, biliary complications, patient survival, graft survival, supplemental oxygen

80% fraction of inspired oxygen delivered either by a nonrebreathing facemask with a reservoir with oxygen flow of 14 l/min and air flow of 2 l/min or by a respirator for first 6 postoperative hours

28% fraction of inspired oxygen delivered either by a Venturi facemask or by a respirator for first 6 postoperative hours

80% fraction of inspired oxygen delivered for 6 postoperative hours, either by a nonrebreathing facemask with a reservoir or by a respirator

28% fraction of inspired oxygen delivered for 6 postoperative hours, either by a Venturi facemask or by a respirator

Occurrence of postoperative infection defined according to the Centers for Disease Control and Prevention (Am J Infect Control 2008; 36: 309-32)

One or more of the following: bilirubin >or=10mg/dL on postoperative day 7, international normalized ratio >or=1.6 on postoperative day 7, alanine or aspartate aminotransferases >2000 IU/L within the first postoperative 7 days (Olthoff et al, Liver Transpl 2010; 16: 943-9)

Inclusion Criteria: active liver transplant waitlist status Exclusion Criteria: active infection at the time of transplantation malignancy cardiac arrest during transplantation chronic obstructive pulmonary disease acute myocardial infarction

The datasets used and/or analysed during the current study are available from the investigators on reasonable request.