Postoperative Supplemental Oxygen in Liver Transplantation

Infection Clinical Trial

— PSOLT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02857855
• Other study ID #: 1WB/1/23/06/2016
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 27, 2016
• Est. completion date: April 2025

Study information

• Verified date: January 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 193
• Est. completion date: April 2025
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Infections

Intervention

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
• 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

Locations

Country	Name	City	State
Poland	Department of General, Transplant and Liver Surgery, Medical University of Warsaw	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biliary complications	Biliary complications requiring endoscopic, percutaneous or surgical intervention	5 years
Secondary	Postoperative mortality		90 days
Secondary	Severe postoperative complications	>= grade 3 according to Clavien-Dindo classification	90 days
Secondary	Patient survival		5 years
Secondary	Graft survival		5 years
Secondary	Postoperative hospital stay		1 year
Secondary	Postoperative intensive care unit stay		1 year
Secondary	Serum aspartate aminotransferase activity		5 days
Secondary	Serum alanine aminotransferase activity		5 days
Secondary	Serum bilirubin concentration		5 days
Secondary	International normalized ratio		5 days
Secondary	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
Secondary	Pulmonary complications		30 days