- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818218
Superior Vena Cava and Its Relationship to Central Venous Pressure Measurements in Liver Transplantation
Superior Vena Cava (SVC) Diameter and Collapsibility Index and Its Relationship to Central Venous Pressure (CVP) Measurements in Patients Undergoing Liver Transplantation
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age
- undergoing liver transplantation surgery (cadaveric and living related)
Exclusion Criteria:
- Contraindication to Transesophageal echocardiography
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
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
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. |
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)
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.
|
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)
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.
|
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac Index
Time Frame: From the time patients enter the operating room to leaving the operating room, up to 24 hours.
|
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.
|
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.
|
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. |
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.
|
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.
|
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.
|
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.
|
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Sessler, Outcomes Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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.
Clinical Trials on Liver Failure
-
Beijing Continent Pharmaceutical Co, Ltd.RecruitingAcute-On-Chronic Liver Failure | Acute Liver FailureChina
-
GenfitCompletedAcute-on-Chronic Liver FailureUnited States
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver FailureIndia
-
HLB Cell Co., Ltd.UnknownAcute-On-Chronic Liver Failure | Acute Liver FailureKorea, Republic of
-
Tianjin Weikai Bioeng., Ltd.Tianjin Nankai HospitalUnknownLiver Failure, Acute on ChronicChina
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver Failure | Acute on Chronic Liver FailureIndia
-
Third Affiliated Hospital, Sun Yat-Sen UniversityWithdrawnLiver Failure, Acute on ChronicChina
-
Institute of Liver and Biliary Sciences, IndiaNot yet recruiting
-
Institute for Clinical and Experimental MedicineRecruiting
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingAcute on Chronic Liver Failure (ACLF)Italy
Clinical Trials on Liver Transplant
-
Mayo ClinicCompleted
-
Azienda Ospedaliero-Universitaria di ModenaRecruitingLiver Metastasis Colon Cancer | Colon AdenocarcinomaItaly
-
Oslo University HospitalRecruitingBile Duct Cancer | Klatskin Tumor | Perihilar CholangiocarcinomaNorway
-
The Third Xiangya Hospital of Central South UniversityRenJi Hospital; Qilu Hospital of Shandong University; Second Xiangya Hospital...UnknownBlood Transfusion ComplicationChina
-
Centro Hospitalar de Lisboa CentralOphiomics - Precision MedicineRecruitingRecurrence Tumor | Hepatocellular Carcinoma, ScirrhousPortugal
-
Izmir Bakircay UniversityIzmir University of Economics Medical Point HospitalRecruitingLiver Transplantation | Cirrhosis | End-Stage Liver DiseaseTurkey (Türkiye)
-
Oslo University HospitalRecruitingIntrahepatic CholangiocarcinomaNorway
-
Azienda Ospedaliera di PadovaIstituto Oncologico Veneto IRCCSRecruitingColorectal Adenocarcinoma | Colorectal Liver Metastases | Unresectable Malignant NeoplasmItaly
-
Methodist Health SystemEnrolling by invitationLiver Transplant Infection | Kidney Transplant Infection | Polyomavirus Infections | BK ViremiaUnited States