NCT02857855

Postoperative Supplemental Oxygen in Liver Transplantation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection

Interventions

Type	Name	Description
PROCEDURE	80% 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
PROCEDURE	28% 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

Timeline

• Start date: 2016-07-27
• Primary completion: 2020-04-07
• Completion: 2025-04-01
• First posted: 2016-08-05
• Last updated: 2023-01-12

Locations

1 site across 1 country: Poland