Postoperative Supplemental Oxygen in Liver Transplantation (PSOLT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infection
• Intervention / Treatment: Procedure: 80% fraction of inspired oxygen for 6 postoperative hours; Procedure: 28% fraction of inspired oxygen for 6 postoperative hours

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 Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-097
      • Department of General, Transplant and Liver Surgery, Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 80% fraction of inspired oxygen; 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; 80% fraction of inspired oxygen delivered for 6 postoperative hours, either by a nonrebreathing facemask with a reservoir or by a respirator
Active Comparator: 28% fraction of inspired oxygen; 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; 28% fraction of inspired oxygen delivered for 6 postoperative hours, either by a Venturi facemask or by a respirator

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Michał Grąt, M.D., PhD., Department of General, Transplant and Liver Surgery, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2016
• Primary Completion (Actual): April 7, 2020
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: liver transplantation; graft survival; supplemental oxygen; postoperative infection; biliary complications; patient survival
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 1WB/1/23/06/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The datasets used and/or analysed during the current study are available from the investigators on reasonable request.