Liver TransplantationCIMT-LIVERNCT07660679
Effect of Preoperative CIMT on Hemodynamics During Liver Transplantation
An observational study of Liver Transplantation and Carotid Intima-media Thickness, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Carotid Intima-media Thickness
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years and older
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dicle University Faculty of Medicine, Department of Anesthesiology and Reanimation
Diyarbakır, 21280
İbrahim Andan, asst. prof., +905059051167, ibrahimandan@hotmail.com
About this study
Official title: 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.
Read the 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).
- Keywords
- Liver Transplantation, Hemodynamics, Preoperative Assessment
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Preoperative Carotid Intima-Media Thickness on Intraoperative Hemodynamic Profile in Liver Transplant Patients
Correlation Between Preoperative Carotid Intima-Media Thickness and Intraoperative Mean Arterial Pressure
Measured: from january 2023 to july 2026
Correlation Between Preoperative Carotid Intima-Media Thickness and Intraoperative Vasopressor Consumption
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.
Measured: from jan 2023 to july 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start11 Feb 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayhan Kaydu, Dicle University
- Investigators
- AYHAN KAYDU, assoc. prof., Study director, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660679
- Sponsor's protocol ID
- 151-2026
- Acronym
- CIMT-LIVER
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Torrijos Y, Ampuero J, Romero-Gomez M. Cardiovascular assessment in liver transplant for non-alcoholic steatohepatitis patients: What we do, what we should do. World J Hepatol. 2017 May 28;9(15):697-703. doi: 10.4254/wjh.v9.i15.697.
PubMed 28596817Perito ER, Phelps A, Vase T, Feldstein VA, Lustig RH, Rosenthal P. Subclinical Atherosclerosis in Pediatric Liver Transplant Recipients: Carotid and Aorta Intima-Media Thickness and Their Predictors. J Pediatr. 2018 Feb;193:119-127.e1. doi: 10.1016/j.jpeds.2017.10.006. Epub 2017 Dec 7.
PubMed 29224938Crouse JR 3rd, Raichlen JS, Riley WA, Evans GW, Palmer MK, O'Leary DH, Grobbee DE, Bots ML; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007 Mar 28;297(12):1344-53. doi: 10.1001/jama.297.12.1344. Epub 2007 Mar 25.
PubMed 17384434Ripoll C, Yotti R, Bermejo J, Banares R. The heart in liver transplantation. J Hepatol. 2011 Apr;54(4):810-22. doi: 10.1016/j.jhep.2010.11.003. Epub 2010 Nov 11.
PubMed 21145840Maggi P, Calo F, Messina V, Stornaiuolo G, Stanzione M, Rinaldi L, De Pascalis S, Macera M, Coppola N. Cardiovascular disease risk in liver transplant recipients transplanted due to chronic viral hepatitis. PLoS One. 2022 Mar 16;17(3):e0265178. doi: 10.1371/journal.pone.0265178. eCollection 2022.
PubMed 35294954
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Carotid Intima-Media Thickness on Intraoperative Hemodynamic Profile in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT07660679
- Acronym / sponsor ID
- CIMT-LIVER / 151-2026
- Keywords
- Liver Transplantation, Hemodynamics, Preoperative Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 22 Jun 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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
The Effect of Preoperative Carotid Intima-Media Thickness on Intraoperative Hemodynamic Profile in Liver Transplant Patients
Time frame: from january 2023 to july 2026
Correlation Between Preoperative Carotid Intima-Media Thickness and Intraoperative Mean Arterial Pressure
Correlation Between Preoperative Carotid Intima-Media Thickness and Intraoperative Vasopressor Consumption
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 28596817Sanchez-Torrijos Y, Ampuero J, Romero-Gomez M. Cardiovascular assessment in liver transplant for non-alcoholic steatohepatitis patients: What we do, what we should do. World J Hepatol. 2017 May 28;9(15):697-703. doi: 10.4254/wjh.v9.i15.697.
- Background: PubMed 29224938Perito ER, Phelps A, Vase T, Feldstein VA, Lustig RH, Rosenthal P. Subclinical Atherosclerosis in Pediatric Liver Transplant Recipients: Carotid and Aorta Intima-Media Thickness and Their Predictors. J Pediatr. 2018 Feb;193:119-127.e1. doi: 10.1016/j.jpeds.2017.10.006. Epub 2017 Dec 7.
- Background: PubMed 17384434Crouse JR 3rd, Raichlen JS, Riley WA, Evans GW, Palmer MK, O'Leary DH, Grobbee DE, Bots ML; METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA. 2007 Mar 28;297(12):1344-53. doi: 10.1001/jama.297.12.1344. Epub 2007 Mar 25.
- Background: PubMed 21145840Ripoll C, Yotti R, Bermejo J, Banares R. The heart in liver transplantation. J Hepatol. 2011 Apr;54(4):810-22. doi: 10.1016/j.jhep.2010.11.003. Epub 2010 Nov 11.
- Background: PubMed 35294954Maggi P, Calo F, Messina V, Stornaiuolo G, Stanzione M, Rinaldi L, De Pascalis S, Macera M, Coppola N. Cardiovascular disease risk in liver transplant recipients transplanted due to chronic viral hepatitis. PLoS One. 2022 Mar 16;17(3):e0265178. doi: 10.1371/journal.pone.0265178. eCollection 2022.
- 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.
AYHAN KAYDU, assoc. prof. study director
Dicle 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 Transplantation and Carotid Intima-media Thickness, run by Dicle 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ibrahim andan, Asst. Prof. (+905059051167, ibrahimandan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Preoperative Carotid Intima-Media Thickness on Intraoperative Hemodynamic Profile in Liver Transplant Patients (time frame: from january 2023 to july 2026). The study lists 2 primary outcomes in all. 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 NCT07660679, which also lists 5 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 23 Jun 2026.