Liver Transplant; Complicationsp50NCT06660095
Intraoperative "p50" Measurement in Liver Transplant Surgeries
An observational study of Liver Transplant; Complications, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant; Complications
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2024to 21 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İnönü Üniversitesi Merkez Kampüsü (Elazığ Yolu 15.km) Battalgazi
Malatya, 44280
About this study
Official title: "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.
Read the 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.
- Conditions
- Liver Transplant; Complications
- Keywords
- Liver transplant, anesthesia, Blood gas analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
p50 changes during liver transplant surgery
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start22 Oct 2024
- Primary completion21 Dec 2024 (estimated)
- Study completion21 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Ziya ÇOLAK, Inonu University
- Investigators
- Muharrem UCAR, assoc.Prof., Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660095
- Sponsor's protocol ID
- Inonu p50
- Acronym
- p50
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35953629Hall 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.
PubMed 23482506
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Investigation of the Clinical Predictive Value of p50 Value in Liver Transplant Surgeries"
- ClinicalTrials.gov ID
- NCT06660095
- Acronym / sponsor ID
- p50 / Inonu p50
- Conditions
- Liver Transplant; Complications
- Keywords
- Liver transplant, anesthesia, Blood gas analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 21 Dec 2024 (estimated)
- Study completion
- 21 Jan 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- 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 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- Patients with fulminant liver failure,
- hepatic encephalopathy,
- hepatorenal,
- hepatopulmonary syndrome,
- uncontrolled diabetes mellitus,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Results publication: PubMed 35953629Kim 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.
- Results publication: PubMed 23482506Hall 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.
- Individual participant dataSharing planned: No
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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.
Muharrem UCAR, assoc.Prof. study director
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications, run by Inonu University at 1 site in Turkey (Türkiye).
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 8 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 26 Oct 2024. 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 Turkey (Türkiye). 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?
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). 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 NCT06660095, which also lists 2 linked publications.
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 26 Oct 2024.