Postoperative Supplemental Oxygen in Liver Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Postoperative Oxygen Therapy on the Results of Liver Transplantation

Conditions
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Infection

Intervention / Treatment
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* Procedure: 80% fraction of inspired oxygen for 6 postoperative hours
* Procedure: 28% fraction of inspired oxygen for 6 postoperative hours


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 80% fraction of inspired oxygen<br>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 | Procedure: 80% fraction of inspired oxygen for 6 postoperative hours<br>* 80% fraction of inspired oxygen delivered for 6 postoperative hours, either by a nonrebreathing facemask with a reservoir or by a respirator<br>|
| Active Comparator: 28% fraction of inspired oxygen<br>28% fraction of inspired oxygen delivered either by a Venturi facemask or by a respirator for first 6 postoperative hours | Procedure: 28% fraction of inspired oxygen for 6 postoperative hours<br>* 28% fraction of inspired oxygen delivered for 6 postoperative hours, either by a Venturi facemask or by a respirator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biliary complications | Biliary complications requiring endoscopic, percutaneous or surgical intervention | 5 years | 
| Postoperative mortality |  | 90 days | 
| Severe postoperative complications | >= grade 3 according to Clavien-Dindo classification | 90 days | 
| Patient survival |  | 5 years | 
| Graft survival |  | 5 years | 
| Postoperative hospital stay |  | 1 year | 
| Postoperative intensive care unit stay |  | 1 year | 
| Serum aspartate aminotransferase activity |  | 5 days | 
| Serum alanine aminotransferase activity |  | 5 days | 
| Serum bilirubin concentration |  | 5 days | 
| International normalized ratio |  | 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) | 7 days | 
| Pulmonary complications |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver transplantation, postoperative infection, biliary complications, patient survival, graft survival, supplemental oxygen