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

2026년 6월 18일 업데이트: 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.

연구 개요

상세 설명

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).

연구 유형

관찰

등록 (추정된)

54

연락처 및 위치

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연구 연락처

연구 연락처 백업

  • 이름: ayhan kaydu, Assoc. Prof.
  • 전화번호: +90 505 556 79 39
  • 이메일: akaydu@hotmail.com

연구 장소

      • Diyarbakır, 터키 (Türkiye), 21280
        • 모병
        • Dicle University Faculty of Medicine, Department of Anesthesiology and Reanimation
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

확률 샘플

연구 인구

Patients aged 18 years and older

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The Effect of Preoperative Carotid Intima-Media Thickness on Intraoperative Hemodynamic Profile in Liver Transplant Patients
기간: 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
기간: 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

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 책임자: AYHAN KAYDU, assoc. prof., Dicle University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 2월 11일

기본 완료 (추정된)

2026년 7월 1일

연구 완료 (추정된)

2026년 7월 1일

연구 등록 날짜

최초 제출

2026년 6월 16일

QC 기준을 충족하는 최초 제출

2026년 6월 16일

처음 게시됨 (실제)

2026년 6월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 18일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 151-2026

개별 참가자 데이터(IPD) 계획

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아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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