InfectionPSOLTNCT02857855
Postoperative Supplemental Oxygen in Liver Transplantation
A study testing 80% fraction of inspired oxygen for 6 postoperative hours and 28% fraction of inspired oxygen for 6 postoperative hours in people with Infection, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- 80% fraction of inspired oxygen for 6 postoperative hours and 28% fraction of inspired oxygen for 6 postoperative hours
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 sitePoland
- Study dates
- 27 Jul 2016to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- active liver transplant waitlist status
Who cannot join
- active infection at the time of transplantation
- malignancy
- cardiac arrest during transplantation
- chronic obstructive pulmonary disease
- acute myocardial infarction
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
About this study
Official title: 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.
Read the 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.
- Conditions
- Infection
- Being tested
- 80% fraction of inspired oxygen for 6 postoperative hours, 28% fraction of inspired oxygen for 6 postoperative hours
- Keywords
- liver transplantation, postoperative infection, biliary complications, patient survival, graft survival, supplemental oxygen
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
80% fraction of inspired oxygen for 6 postoperative hoursProcedure or surgery
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 hoursProcedure or surgery
28% fraction of inspired oxygen delivered for 6 postoperative hours, either by a Venturi facemask or by a respirator
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: 28% fraction of inspired oxygen for 6 postoperative hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (13)
Biliary complications
Biliary complications requiring endoscopic, percutaneous or surgical intervention
Measured: 5 years
Postoperative mortality
Measured: 90 days
Severe postoperative complications
>= grade 3 according to Clavien-Dindo classification
Measured: 90 days
Patient survival
Measured: 5 years
Graft survival
Measured: 5 years
Postoperative hospital stay
Measured: 1 year
Postoperative intensive care unit stay
Measured: 1 year
Serum aspartate aminotransferase activity
Measured: 5 days
Serum alanine aminotransferase activity
Measured: 5 days
Serum bilirubin concentration
Measured: 5 days
International normalized ratio
Measured: 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)
Measured: 7 days
Pulmonary complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start27 Jul 2016
- Primary completion7 Apr 2020
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michał Grąt, M.D., PhD., Principal investigator, Department of General, Transplant and Liver Surgery, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857855
- Sponsor's protocol ID
- 1WB/1/23/06/2016
- Acronym
- PSOLT
- Status last verified
- Jan 2023
- First submitted
- 28 Jul 2016
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the investigators on reasonable request.
Publications
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.
PubMed 36782227
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Postoperative Oxygen Therapy on the Results of Liver Transplantation
- ClinicalTrials.gov ID
- NCT02857855
- Acronym / sponsor ID
- PSOLT / 1WB/1/23/06/2016
- Conditions
- Infection
- Keywords
- liver transplantation, postoperative infection, biliary complications, patient survival, graft survival, supplemental oxygen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 80% fraction of inspired oxygen | Experimental | Procedure: 80% fraction of inspired oxygen for 6 postoperative hours80% 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 |
| 28% fraction of inspired oxygen | Active comparator | Procedure: 28% fraction of inspired oxygen for 6 postoperative hours28% fraction of inspired oxygen delivered either by a Venturi facemask or by a respirator for first 6 postoperative hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- active liver transplant waitlist status
Key exclusion criteria (5 listed)
- active infection at the time of transplantation
- malignancy
- cardiac arrest during transplantation
- chronic obstructive pulmonary disease
- acute myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 80% fraction of inspired oxygen for 6 postoperative hours80% fraction of inspired oxygen delivered for 6 postoperative hours, either by a nonrebreathing facemask with a reservoir or by a respirator | Procedure or surgery | 80% fraction of inspired oxygen |
| 28% fraction of inspired oxygen for 6 postoperative hours28% fraction of inspired oxygen delivered for 6 postoperative hours, either by a Venturi facemask or by a respirator | Procedure or surgery | 28% fraction of inspired oxygen |
Primary outcome
Number of patients with postoperative infections
Time frame: 30 days
Occurrence of postoperative infection defined according to the Centers for Disease Control and Prevention (Am J Infect Control 2008; 36: 309-32)
13 secondary outcomes
Biliary complications
Time frame: 5 years
Postoperative mortality
Time frame: 90 days
Severe postoperative complications
Time frame: 90 days
Patient survival
Time frame: 5 years
Graft survival
Time frame: 5 years
Postoperative hospital stay
Time frame: 1 year
Postoperative intensive care unit stay
Time frame: 1 year
Serum aspartate aminotransferase activity
Time frame: 5 days
Serum alanine aminotransferase activity
Time frame: 5 days
Serum bilirubin concentration
Time frame: 5 days
International normalized ratio
Time frame: 5 days
Early allograft dysfunction
Time frame: 7 days
Pulmonary complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 36782227Figiel 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.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the investigators on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michał Grąt, M.D., PhD. principal investigator
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 80% fraction of inspired oxygen for 6 postoperative hours and 28% fraction of inspired oxygen for 6 postoperative hours in people with Infection, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with postoperative infections (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02857855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.