NCT02857855

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

3.7 years

First QC Date

July 28, 2016

Last Update Submit

January 10, 2023

Conditions

Infection

Keywords

liver transplantationpostoperative infectionbiliary complicationspatient survivalgraft survivalsupplemental oxygen

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Biliary complications

    5 years

  • Postoperative mortality

    90 days

  • Severe postoperative complications

    90 days

  • Patient survival

    5 years

  • Graft survival

    5 years

  • +8 more secondary outcomes

Study Arms (2)

80% fraction of inspired oxygen

EXPERIMENTAL

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

28% fraction of inspired oxygen

ACTIVE COMPARATOR

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

Interventions

80% fraction of inspired oxygen for 6 postoperative hoursPROCEDURE

80% fraction of inspired oxygen delivered for 6 postoperative hours, either by a nonrebreathing facemask with a reservoir or by a respirator

80% fraction of inspired oxygen
28% fraction of inspired oxygen for 6 postoperative hoursPROCEDURE

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

28% fraction of inspired oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active liver transplant waitlist status

You may not qualify if:

  • active infection at the time of transplantation
  • malignancy
  • cardiac arrest during transplantation
  • chronic obstructive pulmonary disease
  • acute myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General, Transplant and Liver Surgery, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

Related Publications (1)

  • Figiel W, Niewinski G, Grat M, Krawczyk M, Stypulkowski J, Lewandowski Z, Krasnodebski M, Patkowski W, Zieniewicz K. Postoperative Supplemental Oxygen in Liver Transplantation (PSOLT) does not reduce the rate of infections: results of a randomized controlled trial. BMC Med. 2023 Feb 13;21(1):51. doi: 10.1186/s12916-023-02741-w.

    PMID: 36782227DERIVED

MeSH Terms

Conditions

Infections

Study Officials

  • Michał Grąt, M.D., PhD.

    Department of General, Transplant and Liver Surgery, Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 5, 2016

Study Start

July 27, 2016

Primary Completion

April 7, 2020

Study Completion

April 1, 2025

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

The datasets used and/or analysed during the current study are available from the investigators on reasonable request.

Locations

PL(1)