The Impact of Postoperative Oxygen Therapy on the Results of Liver Transplantation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Infection
- Sponsor
- Medical University of Warsaw
- Enrollment
- 193
- Locations
- 1
- Primary Endpoint
- Number of patients with postoperative infections
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of patients with postoperative infections
Time Frame: 30 days
Occurrence of postoperative infection defined according to the Centers for Disease Control and Prevention (Am J Infect Control 2008; 36: 309-32)
Secondary Outcomes
- Graft survival(5 years)
- International normalized ratio(5 days)
- Serum alanine aminotransferase activity(5 days)
- Postoperative hospital stay(1 year)
- Biliary complications(5 years)
- Severe postoperative complications(90 days)
- Patient survival(5 years)
- Serum aspartate aminotransferase activity(5 days)
- Postoperative intensive care unit stay(1 year)
- Serum bilirubin concentration(5 days)
- Postoperative mortality(90 days)
- Early allograft dysfunction(7 days)
- Pulmonary complications(30 days)