THE EFFECT OF PREOPERATIVE CAROTID INTIMA-MEDIA THICKNESS ON INTRAOPERATIVE HEMODYNAMIC PROFILE

June 16, 2026 updated by: Ayhan Kaydu, Dicle University

THE EFFECT OF PREOPERATIVE CAROTID INTIMA MEDIA THICKNESS ON INTRAOPERATIVE HEMODYNAMIC PROFILE IN LIVER TRANSPLANT PATIENTS

Candidates for liver transplantation (CT) carry an increased risk of cardiovascular disease (CVD) due to underlying end-stage liver disease (ESHD) and immunosuppressive drugs used post-transplantation. CVD is a significant cause of long-term mortality after CT [1] [2]. Carotid Intima-Media Thickness (CIMT), a subclinical marker of atherosclerosis in the preoperative period, is a non-invasive method used to predict future CVD risk [3]. High CIMT indicates atherosclerosis and decreased arterial compliance. This can compromise organ perfusion and increase the risk of postoperative complications by increasing intraoperative blood pressure variability (BPV) during anesthesia induction and surgical stress in major surgeries such as CT. Studies investigating whether CIMT is an independent risk factor for perioperative hemodynamic instability in CT patients are limited. The aim of our study is to investigate the effect of CIMT values on intraoperative hemodynamic parameters. Secondary objectives are to determine the association of CIMT with the incidence of hypotension, vasopressor requirement, postoperative acute renal injury (ARI), and major cardiac adverse events (MCAE) after anesthesia induction.

Theoretical Benefit: To make a significant contribution to the literature on the relationship between atherosclerosis and anesthesia management by determining whether CIMT is an independent predictor of perioperative hemodynamic instability in chemotherapy patients.

Practical Benefit: To ensure the inclusion of CIMT measurement in the anesthesia risk assessment of chemotherapy candidates. Identifying patients with high CIMT will guide the implementation of more aggressive and targeted hemodynamic management strategies (e.g., more frequent invasive monitoring, proactive vasopressor use) during anesthesia induction and maintenance.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study was planned as a retrospective observational cohort design to examine the relationship between carotid intima-media thickness (CIMT), routinely measured preoperatively and recorded by operating room devices, and intraoperative hemodynamic changes in patients undergoing liver transplantation.

Liver transplantation is an advanced surgical procedure performed with a limited number of high-risk patients. CIMT measurement is a non-invasive ultrasonographic method routinely applied in clinical practice as part of cardiovascular risk assessment in liver transplant candidates. Intraoperative hemodynamic data are recorded as standard by operating room information systems.

Therefore, the present study was planned by retrospectively analyzing data obtained in clinical practice, without introducing any additional intervention or risk to the patient. Retrospective design is considered a suitable method for evaluating rare outcomes (such as reperfusion syndrome) and analyzing real-life data. Retrospective, observational cohort study Inclusion criteria: Patients over 18 years of age who underwent liver transplantation (LT) at Dicle University Faculty of Medicine Hospital between January 1, 2023 and January 28, 2026, provided written informed consent, and had preoperative CIMT measurements will be evaluated.

Exclusion criteria: Patients with carotid artery stenosis or plaque greater than 50%, a history of stroke or transient ischemic attack (TIA), and serious arrhythmias or heart failure that would affect the reliability of intraoperative hemodynamic data.

Materials and Methods:

The mean CIMT (mm) value measured by standard ultrasound in the preoperative period will be used. Intraoperative Data: All hemodynamic data (MAP, HR, vasopressor doses) from anesthesia induction to the end of surgery are measured every 2-5 minutes via automated recording systems. Intraoperative data will be reviewed and evaluated from the existing recording system.

Explanation Regarding Statistical Methods to be Used: Mean ± SD or Median (MESD) will be used for continuous variables, and n (%) for categorical variables.

For continuous variables, Independent Samples t-Test or Mann-Whitney U Test will be used. For categorical variables, Chi-square Test or Fisher's Exact Test will be used.

The relationship between CIMT value and continuous variables such as KBV, duration of hypotension, and vasopressor dose will be examined using Pearson or Spearman Correlation Analysis. To determine whether CIMT is an independent risk factor for intraoperative hypotension or high KBV, Logistic Regression Analysis (for binary results) or Linear Regression Analysis (for continuous results) will be used, controlling for other clinical variables (age, MELD, BMI, etc.).

All analyses will be performed using [Statistical Software Name: E.g., SPSS 25.0, R, etc.] and p < 0.05 will be considered significant.

Power Analysis:

Since the study was planned retrospectively, the sample size was not predetermined. The adequacy of the current sample size was evaluated based on the development of reperfusion syndrome (RS), which is the primary endpoint. In the literature, the incidence of RS in liver transplant patients is reported to be approximately 30-40%. Accordingly, the expected number of RS events in a sample of N=50 patients was calculated to be approximately 15-20.

Considering the events per variable (EPV ≥10) approach recommended for logistic regression analysis, the current sample size was evaluated as sufficient for a predictive model with a limited number of independent variables.

In addition, in the evaluation performed for ROC analysis, it was predicted that the current sample size provided statistical power close to 80% under the assumption of moderate effect size (AUC ≈ 0.70).

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: ayhan kaydu, Assoc. Prof.
  • Phone Number: +90 505 556 79 39
  • Email: akaydu@hotmail.com

Study Locations

  • Turkey (Türkiye)
      • Diyarbakır, Turkey (Türkiye), 21280
        • Recruiting
        • Dicle University Faculty of Medicine, Department of Anesthesiology and Reanimation
        • Contact:

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

Probability Sample

Study Population

All patients over 18 years of age undergoing liver transplantation (LT) will be evaluated.

Description

Inclusion Criteria:

  • Patients over 18 years of age who underwent liver transplantation (LT) at Dicle University Faculty of Medicine Hospital between January 1, 2023 and January 28, 2026, provided written informed consent, and had preoperative CIMT measurements will be evaluated.

Exclusion Criteria: Patients with carotid artery stenosis or plaque exceeding 50%, a history of stroke or transient ischemic attack (TIA), and serious arrhythmias or heart failure that would affect the reliability of intraoperative hemodynamic data.

-

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
This study includes a single group of liver transplant recipients.
Patients aged 18 and over who underwent liver transplantation (LT) at Dicle University Faculty of Medicine Hospital between January 1, 2023, and January 28, 2026, provided written informed consent, and had preoperative carotid intima-media thickness measurements will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RELATIONSHIP BETWEEN CAROTID INTIMA-MEDIA THICKNESS AND HEMODYNAMIC PARAMETERS IN LIVER TRANSPLANT RECIPIENTS
Time Frame: from january 2023 to july 2026
The mean carotid intima-media thickness (mm) value measured by standard ultrasound in the preoperative period will be used. Intraoperative Data: All hemodynamic data (MAP, HR, vasopressor doses) from anesthesia induction to the end of surgery are measured every 2-5 minutes via automated recording systems. Intraoperative data will be reviewed and evaluated from the existing recording system.
from january 2023 to july 2026
Relationship between carotid intima-media thickness and hemodynamic parameters in liver transplant recipients.
Time Frame: from jan 2023 to july 2026
The mean carotid intima-media thickness (mm) value measured by standard ultrasound in the preoperative period will be used. Intraoperative Data: All hemodynamic data (MAP, HR, vasopressor doses) from anesthesia induction to the end of surgery are measured every 2-5 minutes via automated recording systems. Intraoperative data will be reviewed and evaluated from the existing recording system.
from jan 2023 to july 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dicle University

Investigators

  • Study Director: AYHAN KAYDU, assoc. prof., Dicle 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

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)

February 11, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 151/FEB11, 2026

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.

Clinical Trials on Liver Transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe