NCT06660095

Brief 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 of the patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

October 22, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 24, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

Liver transplantanesthesiaBlood gas analysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İnönü Üniversitesi Merkez Kampüsü (Elazığ Yolu 15.km) Battalgazi

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (2)

  • 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 Officials

  • Muharrem UCAR, assoc.Prof.

    Inonu University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Muharrem Ucar, MD.

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 26, 2024

Study Start

October 22, 2024

Primary Completion

December 21, 2024

Study Completion

January 21, 2025

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations