SVC and Its Relationship to CVP Measurements in Liver Transplantation

March 7, 2023 updated by: The Cleveland Clinic

SVC Diameter and Collapsibility Index and Its Relationship to Central Venous Pressure Measurements in Patients Undergoing Liver Transplantation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindication to Transesophageal echocardiography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Superior vena cava (SVC) diameter
Time Frame: during surgery
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Superior vena cava (SVC) diameter
Time Frame: during surgery
during surgery
Change in Superior vena cava (SVC) collapsibility index
Time Frame: during surgery
during surgery
Superior vena cava (SVC) collapsibility index
Time Frame: during surgery
It is a measure of the inspiratory decrease in SVC diameter will be determined
during surgery
Correlation between SVC measurements and cardiac output/cardiac index
Time Frame: during surgery
Assess the correlation between SVC measurements and cardiac output/cardiac index
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Study Chair: Daniel Sessler, M.D., Chair of Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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