Liver FailureNCT02818218

Superior Vena Cava and Its Relationship to Central Venous Pressure Measurements in Liver Transplantation

An observational study of Liver Failure, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Consecutive patients undergoing liver transplant surgery will be included in the study. Before surgical incision, during the preanhepatic phase, during the anhepatic phase, during the postanhepatic phase and following closure of the deep fascial layer of the anterior abdominal wall simultaneous measurement of SVC… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Liver Failure
What is being tested?: Liver Transplant
Type of treatment: Surgery or procedure
How many people: 58 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2016to Sep 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients undergoing liver transplantation surgery (cadaveric and living related)

Who may be able to join

18 years of age
undergoing liver transplantation surgery (cadaveric and living related)

Who cannot join

Contraindication to Transesophageal echocardiography

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Foundation
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Superior Vena Cava (SVC) Diameter and Collapsibility Index and Its Relationship to Central Venous Pressure (CVP) Measurements in Patients Undergoing Liver Transplantation

Read the detailed description

Central venous pressure (CVP) measured invasively through a central venous catheter in the internal jugular vein or through a right atrial port of a pulmonary artery catheter is commonly used during liver transplant surgery. CVP measurements at the SVC-RA junction are a function of circulating blood volume, right ventricle function, intrathoracic pressure. CVP measurements can also be affected by the presence of tricuspid regurgitation. Because central venous pressure measurements are determined by several factors and do not predict the response to subsequent fluid bolus administration, they are considered "static measures" and are poor indicators of fluid responsiveness.

Given the entirely intrathoracic location of the superior vena cava (SVC), its diameter and collapsibility with positive pressure ventilation it is a potentially attractive method of non-invasively estimating CVP.

SVC diameter and collapsibility index, dynamic measures of fluid responsiveness have been successfully utilized as echocardiographic indices for fluid responsiveness in ventilated septic patients. Whether SVC collapsibility is correlated with CVP measurements in liver transplant patients is not known.

Conditions: Liver Failure
Being tested: Liver Transplant
Medical subject headings: Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Liver TransplantProcedure or surgery
liver transplant recipient surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Central Venous Pressure (CVP)
Central Venous Pressure (CVP) reflects the amount of blood returning to the heart (venous return) and the ability of the heart to pump the blood into the arterial system. It was captured electronically via an automated record-keeping system. CVP were recorded by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.
Low CVP (< 2 mmHg) suggests hypovolemia, dehydration, or blood loss, while normal CVP (2-8 mmHg) indicates balanced fluid status. A high CVP (> 8 mmHg) may indicate fluid overload, right heart failure, pulmonary hypertension, or cardiac tamponade.
Measured: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Correlation of Central Venous Pressure (CVP) and Superior Vena Cava (SVC) Collapsibility Index
The Superior Vena Cava (SVC) Collapsibility Index is used to assess intravascular volume status and fluid responsiveness. The Superior Vena Cava (SVC) collapsibility index was obtained from (Maximum Diameter-Minimum Diameter)/(Maximum Diameter)*100%. Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.
The interpretation of the SVC Collapsibility Index is categorized as follows: < 20% indicates low collapsibility, suggesting adequate or high intravascular volume; 20-36% represents an indeterminate zone, requiring additional assessment to determine fluid responsiveness; and > 36% reflects high collapsibility, suggesting hypovolemia or significant fluid deficit.
Measured: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Correlation of Central Venous Pressure (CVP) and Minimum Diameter of Superior Vena Cava (SVC)
The diameter of Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.
Measured: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Correlation of Central Venous Pressure (CVP) and Maximum Diameter of Superior Vena Cava (SVC)
The diameter of the Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.
Measured: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

Secondary outcomes (4)

Cardiac Index
The Cardiac Index measures the efficiency of the heart's pumping function (normal range: 2.6 to 4.2 L/min/m2). It was captured electronically via an automated record-keeping system. Cardiac Index was recorded by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.
Measured: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Correlation of Cardiac Index (CI) and Superior Vena Cava (SVC) Collapsibility Index
The Superior Vena Cava (SVC) Collapsibility Index is used to assess intravascular volume status and fluid responsiveness. The Superior Vena Cava (SVC) collapsibility index was obtained from (Maximum Diameter-Minimum Diameter)/(Maximum Diameter)*100%. Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.
The interpretation of the SVC Collapsibility Index is categorized as follows: < 20% indicates low collapsibility, suggesting adequate or high intravascular volume; 20-36% represents an indeterminate zone, requiring additional assessment to determine fluid responsiveness; and > 36% reflects high collapsibility, suggesting hypovolemia or significant fluid deficit.
Measured: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Correlation of Cardiac Index (CI) and Minimum Diameter of Superior Vena Cava (SVC)
The diameter of the Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Cardiac Index and Superior Vena Cava (SVC) were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.
Measured: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Correlation of Cardiac Index (CI) and Maximum Diameter of Superior Vena Cava (SVC)
The diameter of the Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Cardiac Index and Superior Vena Cava (SVC) were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.
Measured: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 2016Sep 2020

First posted29 Jun 2016 (estimated)
Study start1 Jul 2016
Primary completionMay 2019
Study completionSep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Liver FailureStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
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: Prospective
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02818218
Sponsor's protocol ID: 16-307
Status last verified: Aug 2025
First submitted: 11 Apr 2016
Last updated: 7 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Argalious MY, Halvorson S, Seif J, Khanna S, Wang M, Cywinski JB. Assessment of superior vena cava diameter and collapsibility index in liver transplantation: a prospective observational study. Braz J Anesthesiol. 2024 Nov-Dec;74(6):844563. doi: 10.1016/j.bjane.2024.844563. Epub 2024 Oct 9.
PubMed 39383993

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
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Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
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RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
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All Liver Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Superior Vena Cava (SVC) Diameter and Collapsibility Index and Its Relationship to Central Venous Pressure (CVP) Measurements in Patients Undergoing Liver Transplantation
ClinicalTrials.gov ID: NCT02818218
Acronym / sponsor ID: 16-307
Conditions: Liver Failure
Study type: Observational
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: 1 Jul 2016 (actual)
Primary completion: May 2019 (actual)
Study completion: Sep 2020 (actual)
First posted: 29 Jun 2016 (estimated)
Results: Posted 7 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients undergoing liver transplantation surgery (cadaveric and living related)

Key inclusion criteria (2 listed)

18 years of age
undergoing liver transplantation surgery (cadaveric and living related)

Key exclusion criteria (1 listed)

Contraindication to Transesophageal echocardiography

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Liver Transplantliver transplant recipient surgery	Procedure or surgery	–

Primary outcome

Central Venous Pressure (CVP)
Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Central Venous Pressure (CVP) reflects the amount of blood returning to the heart (venous return) and the ability of the heart to pump the blood into the arterial system. It was captured electronically via an automated record-keeping system. CVP were recorded by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall. Low CVP (< 2 mmHg) suggests hypovolemia, dehydration, or blood loss, while normal CVP (2-8 mmHg) indicates balanced fluid status. A high CVP (> 8 mmHg) may indicate fluid overload, right heart failure, pulmonary hypertension, or cardiac tamponade.
Correlation of Central Venous Pressure (CVP) and Superior Vena Cava (SVC) Collapsibility Index
Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
The Superior Vena Cava (SVC) Collapsibility Index is used to assess intravascular volume status and fluid responsiveness. The Superior Vena Cava (SVC) collapsibility index was obtained from (Maximum Diameter-Minimum Diameter)/(Maximum Diameter)*100%. Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall. The interpretation of the SVC Collapsibility Index is categorized as follows: < 20% indicates low collapsibility, suggesting adequate or high intravascular volume; 20-36% represents an indeterminate zone, requiring additional assessment to determine fluid responsiveness; and > 36% reflects high collapsibility, suggesting hypovolemia or significant fluid deficit.
Correlation of Central Venous Pressure (CVP) and Minimum Diameter of Superior Vena Cava (SVC)
Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
The diameter of Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.
Correlation of Central Venous Pressure (CVP) and Maximum Diameter of Superior Vena Cava (SVC)
Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
The diameter of the Superior Vena Cava (normal diameter: 12-22 mm) ) was obtained using transesophageal echocardiography (TEE). Central Venous Pressure (CVP) and SVC were recorded simultaneously by experienced anesthesiologists with expertise and qualifications in TEE at five key time points: before surgical incision, start of the preanhepatic phase, start of the anhepatic phase, start of the postanhepatic phase, and after closure of the deep fascial layer of the anterior abdominal wall.

4 secondary outcomes

Cardiac Index
Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Correlation of Cardiac Index (CI) and Superior Vena Cava (SVC) Collapsibility Index
Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Correlation of Cardiac Index (CI) and Minimum Diameter of Superior Vena Cava (SVC)
Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Correlation of Cardiac Index (CI) and Maximum Diameter of Superior Vena Cava (SVC)
Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

Results and safety

Results posted to the registry on 7 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liver Transplantation Patients	58	58

Primary outcome: Central Venous Pressure (CVP)

Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.. Mean (Standard Deviation). Unit: mmHg

Measure	Liver Transplantation Patients n = 58
Value	11.7 (4.9)

Primary outcome: Correlation of Central Venous Pressure (CVP) and Superior Vena Cava (SVC) Collapsibility Index

Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.. Mean (Standard Deviation). Unit: index

Measure	Liver Transplantation Patients n = 58
Value	26 (11)

Liver Transplantation Patients: correlation coefficient: 0.0005 (98.3% CI -0.161 to 0.170), p = 0.944, Repeated measures correlation (rmcorr)

Primary outcome: Correlation of Central Venous Pressure (CVP) and Minimum Diameter of Superior Vena Cava (SVC)

Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.. Mean (Standard Deviation). Unit: mm

Measure	Liver Transplantation Patients n = 58
Value	12.8 (3.1)

Liver Transplantation Patients: correlation coefficient: 0.27 (98.3% CI 0.11 to 0.42), p <0.001, Repeated measures correlation (rmcorr)

Primary outcome: Correlation of Central Venous Pressure (CVP) and Maximum Diameter of Superior Vena Cava (SVC)

Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.. Mean (Standard Deviation). Unit: mm

Measure	Liver Transplantation Patients n = 58
Value	17.3 (3.2)

Liver Transplantation Patients: correlation coefficient: 0.34 (98.3% CI 0.19 to 0.48), p <0.001, Repeated measures correlation (rmcorr)

Population analysed: maximum Superior Vena Cava (SVC)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liver Transplantation Patients	0 of 58 (0%)	0 of 58 (0%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39383993Argalious MY, Halvorson S, Seif J, Khanna S, Wang M, Cywinski JB. Assessment of superior vena cava diameter and collapsibility index in liver transplantation: a prospective observational study. Braz J Anesthesiol. 2024 Nov-Dec;74(6):844563. doi: 10.1016/j.bjane.2024.844563. Epub 2024 Oct 9.
Individual participant dataSharing planned: No

Related trials for Liver Failure

Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure

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. This study is not recruiting at the moment.

Daniel Sessler principal investigator

Outcomes Research Institute

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 Failure, run by The Cleveland Clinic at 1 site in United States.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Aug 2025. 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 United States. 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?

Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Venous Pressure (CVP) (time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.). The study lists 4 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 NCT02818218, which also lists 1 linked publication.

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 7 Aug 2025.