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Effect of Preoperative CIMT on Hemodynamics During Liver Transplantation (CIMT-LIVER)

2026年6月18日 更新者: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.

調査の概要

詳細な説明

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).

研究の種類

観察的

入学 (推定)

54

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前:ayhan kaydu, Assoc. Prof.
  • 電話番号:+90 505 556 79 39
  • メール:akaydu@hotmail.com

研究場所

      • Diyarbakır、トルコ(Türkiye)、21280
        • 募集
        • Dicle University Faculty of Medicine, Department of Anesthesiology and Reanimation
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

確率サンプル

調査対象母集団

Patients aged 18 years and older

説明

Inclusion Criteria:

  • Patients aged between 18 and 65 years
  • Scheduled for elective liver transplantation surgery
  • Completed preoperative carotid intima-media thickness (CIMT) ultrasonographic measurement
  • Patients with signed informed consent for data collection

Exclusion Criteria:

  • Patients undergoing emergency liver transplantation
  • History of previous carotid artery surgery or stenting
  • Known severe carotid artery stenosis (>70%)
  • Severe intraoperative hemodynamic instability prior to induction (e.g., active bleeding or shock)
  • Incomplete intraoperative advanced hemodynamic monitoring data or vasopressor records

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
The Effect of Preoperative Carotid Intima-Media Thickness on Intraoperative Hemodynamic Profile in Liver Transplant Patients
時間枠:from january 2023 to july 2026
Correlation Between Preoperative Carotid Intima-Media Thickness and Intraoperative Mean Arterial Pressure
from january 2023 to july 2026
Correlation Between Preoperative Carotid Intima-Media Thickness and Intraoperative Vasopressor Consumption
時間枠:from jan 2023 to july 2026
The correlation coefficient (r value) will be calculated to assess the linear relationship between preoperative carotid intima-media thickness (measured in millimeters via ultrasonography) and the total dose or duration of intraoperative vasopressor support (e.g., noradrenaline, ephedrine, or dopamine) required to maintain hemodynamic stability.
from jan 2023 to july 2026

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:AYHAN KAYDU, assoc. prof.、Dicle University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年2月11日

一次修了 (推定)

2026年7月1日

研究の完了 (推定)

2026年7月1日

試験登録日

最初に提出

2026年6月16日

QC基準を満たした最初の提出物

2026年6月16日

最初の投稿 (実際)

2026年6月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月23日

QC基準を満たした最後の更新が送信されました

2026年6月18日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 151-2026

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

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いいえ

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