Oxygen Dissociation Curve in Patients Undergoing Orthotopic Liver Transplantation
1 other identifier
observational
30
1 country
1
Brief Summary
Hemoglobin (Hb) is the molecule responsible for the transport of oxygen (O2) to the tissues in mammals. The p50 and the Hill coefficient (HC) best describe the ODC. The interaction between Hb and O2 can be influenced by many agents and conditions like temperature, pH, pCO2 and 2,3-diphosphoglycerate (2,3-DPG). During liver transplantation numerous profound physiological changes occur, linked to the different stages of the surgical procedure. Previous studies in humans and animals undergoing liver transplantation have shown that while the ODC seems preserved during preparation and the anhepatic phase, a left shift of the ODC occurs after reperfusion . This left shift of the ODC could imply a decreased release of oxygen to the tissues, probably worsening hemodynamic instability. With this pilot study the investigator aim to measure ODCs at baseline and at different stages during orthotopic liver transplantation in patients in order to get deeper understanding of oxygen delivery and supply during liver transplantation surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2023
1 active site
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
First Submitted
Initial submission to the registry
April 6, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedMarch 26, 2025
November 1, 2024
1.4 years
April 6, 2023
March 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxygen Dissocation Curve
Oxgen delivery curve characteristics based on p50 values, Hill-coefficient and 2,3 DPG
24 hours
Interventions
ODC will be assessed at 5 timepoints: T0 after installation of arterial catheter, T1 before clamping of the liver, T2 5-10 min before reperfusion of the liver graft, T3 45 min after reperfusion, T4 1 h after T3 or at end of surgery
Eligibility Criteria
Patients scheduled for orthotopic liver transplantation
You may qualify if:
- Patien scheduled for LTX
- Age 18 years to 99 years
- Signed informed content form.
You may not qualify if:
- Known hemoglobinopathy
- Need for more than 3 packed erythrocytes before assessment at T4.
- preoperative predicted need for more than 3 based on study team
- MELD score \< 10
- stay at high attitude (\>3000 m) for more days over the last 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Innsbruck
Innsbruck, Tyrol, 6020, Austria
Biospecimen
Blood
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2023
First Posted
April 20, 2023
Study Start
May 1, 2023
Primary Completion
September 30, 2024
Study Completion
October 31, 2024
Last Updated
March 26, 2025
Record last verified: 2024-11