Postoperative Supplemental Oxygen in Liver Transplantation

Not Applicable

Active, not recruiting

• Conditions: Infection

• Registration Number: NCT02857855
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study Start: 2016-07-27
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Primary Completion: 2020-04-07
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serum alanine aminotransferase activity	5 days
Biliary complications	5 years	Biliary complications requiring endoscopic, percutaneous or surgical intervention
Severe postoperative complications	90 days	\>= grade 3 according to Clavien-Dindo classification
Graft 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
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
Postoperative hospital stay	1 year
Patient survival	5 years

Trial Locations

Locations (1)

Department of General, Transplant and Liver Surgery, Medical University of Warsaw; 🇵🇱 Warsaw, Mazowieckie, Poland