Postoperative Supplemental Oxygen in Liver Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-27

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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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

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

80% fraction of inspired oxygen for 6 postoperative hours

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

28% fraction of inspired oxygen for 6 postoperative hours

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No