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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02818218
Other study ID # 16-307
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2016
Est. completion date June 2024

Study information

Verified date May 2024
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 18 years of age - undergoing liver transplantation surgery (cadaveric and living related) Exclusion Criteria: - Contraindication to Transesophageal echocardiography

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Liver Transplant
liver transplant recipient surgery

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

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