Infection
Conditions
Keywords
liver transplantation, postoperative infection, biliary complications, patient survival, graft survival, supplemental oxygen
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.
Interventions
PROCEDURE80% fraction of inspired oxygen for 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
PROCEDURE28% fraction of inspired oxygen for 6 postoperative hours
28% fraction of inspired oxygen delivered for 6 postoperative hours, either by a Venturi facemask or by a respirator
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with postoperative infections | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative mortality | 90 days | — |
| Severe postoperative complications | 90 days | \>= grade 3 according to Clavien-Dindo classification |
| Patient survival | 5 years | — |
| Graft survival | 5 years | — |
| Postoperative hospital stay | 1 year | — |
| Postoperative intensive care unit stay | 1 year | — |
| Biliary complications | 5 years | Biliary complications requiring endoscopic, percutaneous or surgical intervention |
| Serum alanine aminotransferase activity | 5 days | — |
| Serum bilirubin concentration | 5 days | — |
| International normalized ratio | 5 days | — |
| Early allograft dysfunction | 7 days | 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) |
| Pulmonary complications | 30 days | — |
| Serum aspartate aminotransferase activity | 5 days | — |
Countries
Poland
Outcome results
None listed