Postoperative Supplemental Oxygen in Liver Transplantation (PSOLT)

Medical University of Warsaw

Status: Active, not recruiting

Conditions: Infection

Treatments: Procedure: 28% fraction of inspired oxygen for 6 postoperative hours; Procedure: 80% fraction of inspired oxygen for 6 postoperative hours

Study type: Interventional

Funder types: Other

Identifiers

NCT02857855

1WB/1/23/06/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 193 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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193 participants in 2 patient groups

80% fraction of inspired oxygen

Experimental group

Description:

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

Treatment:

Procedure: 80% fraction of inspired oxygen for 6 postoperative hours

28% fraction of inspired oxygen

Active Comparator group

Description:

28% fraction of inspired oxygen delivered either by a Venturi facemask or by a respirator for first 6 postoperative hours

Treatment:

Procedure: 28% fraction of inspired oxygen for 6 postoperative hours