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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
193
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
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Number of patients with postoperative infections
Occurrence of postoperative infection defined according to the Centers for Disease Control and Prevention (Am J Infect Control 2008; 36: 309-32)
Time frame: 30 days
Biliary complications
Biliary complications requiring endoscopic, percutaneous or surgical intervention
Time frame: 5 years
Postoperative mortality
Time frame: 90 days
Severe postoperative complications
\>= grade 3 according to Clavien-Dindo classification
Time frame: 90 days
Patient survival
Time frame: 5 years
Graft survival
Time frame: 5 years
Postoperative hospital stay
Time frame: 1 year
Postoperative intensive care unit stay
Time frame: 1 year
Serum aspartate aminotransferase activity
Time frame: 5 days
Serum alanine aminotransferase activity
Time frame: 5 days
Serum bilirubin concentration
Time frame: 5 days
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International normalized ratio
Time frame: 5 days
Early allograft dysfunction
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)
Time frame: 7 days
Pulmonary complications
Time frame: 30 days