- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06660095
Intraoperative "p50" Measurement in Liver Transplant Surgeries (p50)
October 24, 2024 updated by: Yusuf Ziya ÇOLAK, Inonu University
"Investigation of the Clinical Predictive Value of p50 Value in Liver Transplant Surgeries"
The aim of this study is to compare the p50 value in routine blood gas measurements taken during liver transplant surgery follow-up with other follow-up parameters and clinical findings on the monitors, and to investigate whether there is a predictive parameter that can predict the rapidly changing clinical findings of the patients.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
Blood gas monitoring is the most commonly method used by anesthetists during liver transplant surgeries.
We evaluated the blood gas p50 value according to the stages in these heart transplant operations.
We tried to find out how the blood gas p50 value would guide the patient's clinical findings in the dissection phase, anhepatic phase and neohepatic phase.
For this purpose, we compared arterial and venous blood gas p50 values with the patient's vital signs at certain stages in liver transplant surgeries.
Study Type
Observational
Enrollment (Estimated)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Malatya, Turkey, 44280
- İnönü Üniversitesi Merkez Kampüsü (Elazığ Yolu 15.km) Battalgazi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Liver transplant recipients who will undergo Elective Liver Transplant surgery at İnönü University Faculty of Medicine Liver Transplant Institute, ASA (American Society of Anesthesiology) score III-IV, patients between the ages of 18-65
Description
Inclusion Criteria:
- Liver transplant recipients who will undergo Elective Liver Transplant surgery at İnönü University Faculty of Medicine Liver Transplant Institute, ASA (American Society of Anesthesiology) score III-IV, patients between the ages of 18-65
Exclusion Criteria:
- Patients with fulminant liver failure,
- hepatic encephalopathy,
- hepatorenal,
- hepatopulmonary syndrome,
- uncontrolled diabetes mellitus,
- cardiovascular, pulmonary disease,
- sepsis
- and patients who refuse consent in the informed consent form will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Liver transplant recipients
T0: After the anesthesia induction, before the surgery T1: Intraoperative p50 value from the blood gas sample taken during the dissection stage T2: Intraoperative p50 value from the blood gas sample taken during the anhepatic stage T3: Intraoperative p50 value from the blood gas sample taken during the neohepatic stage T4: After the hepatic artery reperfusion T5: At the end of the surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
p50 changes during liver transplant surgery
Time Frame: T0: at the end of the dissection before clamps T1: 5 min. before reperfusion (anhepatic) T2: 30 min. after reperfusion of the liver graft (neohepatic) T3: after hepatic artery reperfusion T4: End of the operation
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P50 is the partial pressure of oxygen required to achieve 50% haemoglobin saturation.
The normal p50 value is 24-28 mmHg.
The oxygen-hemoglobin dissociation curve represents the affinity of hemoglobin for oxygen.
The p50 value represents a mid-point in this curve, and gives us information regarding that affinity.
Determining the clinical value, if any, of the changes in p50 values taken at different stages of liver transplantation surgery may be useful in the follow-up of these patients in the future and may help in making intraoperative decisions.
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T0: at the end of the dissection before clamps T1: 5 min. before reperfusion (anhepatic) T2: 30 min. after reperfusion of the liver graft (neohepatic) T3: after hepatic artery reperfusion T4: End of the operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Muharrem UCAR, assoc.Prof., Inonu University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kim Y, Jung JH, Kim GE, Park M, Lee M, Kim SY, Kim MJ, Kim YH, Kim KW, Sohn MH. P50 implies adverse clinical outcomes in pediatric acute respiratory distress syndrome by reflecting extrapulmonary organ dysfunction. Sci Rep. 2022 Aug 11;12(1):13666. doi: 10.1038/s41598-022-18038-6.
- Hall TH, Dhir A. Anesthesia for liver transplantation. Semin Cardiothorac Vasc Anesth. 2013 Sep;17(3):180-94. doi: 10.1177/1089253213481115. Epub 2013 Mar 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 22, 2024
Primary Completion (Estimated)
December 21, 2024
Study Completion (Estimated)
January 21, 2025
Study Registration Dates
First Submitted
October 24, 2024
First Submitted That Met QC Criteria
October 24, 2024
First Posted (Actual)
October 26, 2024
Study Record Updates
Last Update Posted (Actual)
October 26, 2024
Last Update Submitted That Met QC Criteria
October 24, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Inonu p50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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