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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 80% fraction of inspired oxygen | Experimental | 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 | Active Comparator | 28% fraction of inspired oxygen delivered either by a Venturi facemask or by a respirator for first 6 postoperative hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 80% fraction of inspired oxygen for 6 postoperative hours | Procedure | 80% fraction of inspired oxygen delivered for 6 postoperative hours, either by a nonrebreathing facemask with a reservoir or by a respirator |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biliary complications | Biliary complications requiring endoscopic, percutaneous or surgical intervention | 5 years |
| Postoperative mortality | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michał Grąt, M.D., PhD. | Department of General, Transplant and Liver Surgery, Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Transplant and Liver Surgery, Medical University of Warsaw | Warsaw | Masovian Voivodeship | 02-097 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36782227 | Derived | Figiel W, Niewinski G, Grat M, Krawczyk M, Stypulkowski J, Lewandowski Z, Krasnodebski M, Patkowski W, Zieniewicz K. Postoperative Supplemental Oxygen in Liver Transplantation (PSOLT) does not reduce the rate of infections: results of a randomized controlled trial. BMC Med. 2023 Feb 13;21(1):51. doi: 10.1186/s12916-023-02741-w. |
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The datasets used and/or analysed during the current study are available from the investigators on reasonable request.
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| ID | Term |
|---|---|
| D007239 | Infections |
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| 28% fraction of inspired oxygen for 6 postoperative hours | Procedure | 28% fraction of inspired oxygen delivered for 6 postoperative hours, either by a Venturi facemask or by a respirator |
|
| 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 |