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Register:	ClinicalTrials.gov
Last refreshed on:	23 January 2023
Main ID:	NCT02857855
Date of registration:	28/07/2016
Prospective Registration:	No
Primary sponsor:	Medical University of Warsaw
Public title:	Postoperative Supplemental Oxygen in Liver Transplantation PSOLT
Scientific title:	The Impact of Postoperative Oxygen Therapy on the Results of Liver Transplantation
Date of first enrolment:	July 27, 2016
Target sample size:	193
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT02857855
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
Phase:	N/A

Countries of recruitment
Poland

Contacts

Name:	Michal Grat, M.D., PhD.
Address:
Telephone:
Email:
Affiliation:	Department of General, Transplant and Liver Surgery, Medical University of Warsaw

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Infection

Intervention(s)

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

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

Primary Outcome(s)

Number of patients with postoperative infections [Time Frame: 30 days]

Secondary Outcome(s)

International normalized ratio [Time Frame: 5 days]

Biliary complications [Time Frame: 5 years]

Postoperative intensive care unit stay [Time Frame: 1 year]

Patient survival [Time Frame: 5 years]

Serum bilirubin concentration [Time Frame: 5 days]

Postoperative hospital stay [Time Frame: 1 year]

Early allograft dysfunction [Time Frame: 7 days]

Severe postoperative complications [Time Frame: 90 days]

Graft survival [Time Frame: 5 years]

Serum aspartate aminotransferase activity [Time Frame: 5 days]

Pulmonary complications [Time Frame: 30 days]

Serum alanine aminotransferase activity [Time Frame: 5 days]

Postoperative mortality [Time Frame: 90 days]

Secondary ID(s)

1WB/1/23/06/2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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