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CompletedNCT02818218Updated Aug 7, 2025Results posted

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

An observational study in Liver Failure, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
58
Ages
18 Years to 80 Years
Sex
All
01

Study 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 diameter, SBC collapsibility index and CVP will be recorded.

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.

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 diameter, SBC collapsibility index and CVP will be recorded.

02

Conditions studied

  • Liver Failure

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03

In context

Liver Failure

445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.

This study's enrollment of 58 is below the median of 129 across 146 observational studies indexed under Liver Failure.

Browse Liver Failure studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Contraindication to Transesophageal echocardiography
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
58 participants (actual)
Patient registry
No

Interventions

  • ProcedureLiver Transplant

    liver transplant recipient surgery

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

  2. 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.

    Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

  3. 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.

    Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

  4. 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.

    Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

Secondary outcomes

  1. 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.

    Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

  2. 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.

    Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

  3. 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.

    Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

  4. 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.

    Time frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.

07

Results

Posted Aug 7, 2025

Participant flow

Participant flow — Overall Study
MilestoneLiver Transplantation Patients
Started58
Completed58
Not completed0

Outcome measures

PrimaryCentral 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.

Time frame:
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Reported as:
Mean · mmHg
Central Venous Pressure (CVP)
mmHgLiver Transplantation Patients
Central Venous Pressure (CVP)11.7 ± 4.9
PrimaryCorrelation 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.

Time frame:
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Reported as:
Mean · index
Correlation of Central Venous Pressure (CVP) and Superior Vena Cava (SVC) Collapsibility Index
indexLiver Transplantation Patients
Correlation of Central Venous Pressure (CVP) and Superior Vena Cava (SVC) Collapsibility Index26 ± 11
Statistical analysis
  • Liver Transplantation Patients · Repeated measures correlation (rmcorr) · p = 0.944 · Correlation coefficient: 0.0005 · 98.3% CI -0.161 to 0.170The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa
PrimaryCorrelation 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.

Time frame:
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Reported as:
Mean · mm
Correlation of Central Venous Pressure (CVP) and Minimum Diameter of Superior Vena Cava (SVC)
mmLiver Transplantation Patients
Correlation of Central Venous Pressure (CVP) and Minimum Diameter of Superior Vena Cava (SVC)12.8 ± 3.1
Statistical analysis
  • Liver Transplantation Patients · Repeated measures correlation (rmcorr) · p = <0.001 · Correlation coefficient: 0.27 · 98.3% CI 0.11 to 0.42The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa
PrimaryCorrelation 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.

Time frame:
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Reported as:
Mean · mm
Correlation of Central Venous Pressure (CVP) and Maximum Diameter of Superior Vena Cava (SVC)
mmLiver Transplantation Patients
Correlation of Central Venous Pressure (CVP) and Maximum Diameter of Superior Vena Cava (SVC)17.3 ± 3.2
Statistical analysis
  • Liver Transplantation Patients · Repeated measures correlation (rmcorr) · p = <0.001 · Correlation coefficient: 0.34 · 98.3% CI 0.19 to 0.48The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa
SecondaryCardiac 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.

Time frame:
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Reported as:
Mean · L/min/m2
Cardiac Index
L/min/m2Liver Transplantation Patients
Cardiac Index4.4 ± 1.5
SecondaryCorrelation 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.

Time frame:
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Reported as:
Mean · index
Correlation of Cardiac Index (CI) and Superior Vena Cava (SVC) Collapsibility Index
indexLiver Transplantation Patients
Correlation of Cardiac Index (CI) and Superior Vena Cava (SVC) Collapsibility Index26 ± 11
Statistical analysis
  • Liver Transplantation Patients · Repeated measures correlation (rmcorr) · p = 0.298 · Correlation coefficient: 0.07 · 98.3% CI -0.10 to 0.24The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa
SecondaryCorrelation 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.

Time frame:
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Reported as:
Mean · mm
Correlation of Cardiac Index (CI) and Minimum Diameter of Superior Vena Cava (SVC)
mmLiver Transplantation Patients
Correlation of Cardiac Index (CI) and Minimum Diameter of Superior Vena Cava (SVC)12.8 ± 3.1
Statistical analysis
  • Liver Transplantation Patients · Repeated measures correlation (rmcorr) · p = 0.002 · Correlation coefficient: 0.22 · 98.3% CI 0.05 to 0.37The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa
SecondaryCorrelation 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.

Time frame:
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
Reported as:
Mean · mm
Correlation of Cardiac Index (CI) and Maximum Diameter of Superior Vena Cava (SVC)
mmLiver Transplantation Patients
Correlation of Cardiac Index (CI) and Maximum Diameter of Superior Vena Cava (SVC)17.3 ± 3.2
Statistical analysis
  • Liver Transplantation Patients · Repeated measures correlation (rmcorr) · p = <0.001 · Correlation coefficient: 0.33 · 98.3% CI 0.17 to 0.47The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa

Adverse events

Collected over From the time patients enter the operating room to leaving the operating room, up to 24 hours.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Liver Transplantation Patients0/58 (0%)0/58 (0%)0/58 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Liver Transplantation Patients
Median60 (55 to 67)
Sex: Female, Male
Sex: Female, Male(Participants)Liver Transplantation Patients
Female17
Male41
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Liver Transplantation Patients
White48
Other10
Current smoker
Current smoker(Participants)Liver Transplantation Patients
Count of participants26
BMI
BMI(kg/m2)Liver Transplantation Patients
Mean29 ± 6
ASA (American Society of Anesthesiologists) physical status
ASA (American Society of Anesthesiologists) physical status(Participants)Liver Transplantation Patients
3 (Severe systemic illness)3
4 (Life-threatening systemic illness)53
5 (Not expected to survive without the operation)2
Alcoholic Cirrhosis
Alcoholic Cirrhosis(Participants)Liver Transplantation Patients
Count of participants18
Primary Billary Cirrhosis
Primary Billary Cirrhosis(Participants)Liver Transplantation Patients
Count of participants1

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 20, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02818218
Lead sponsor
The Cleveland Clinic
Responsible party
Sponsor
First posted
Jun 29, 2016
Start date
Jul 1, 2016
Primary completion
May 2019
Completion
Sep 2020
Results posted
Aug 7, 2025
Last update
Aug 7, 2025

Study contacts

Daniel Sessler
principal investigator · Outcomes Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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