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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver Transplant | Procedure | liver transplant recipient surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing liver transplantation surgery (cadaveric and living related)
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Sessler | Outcomes Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liver Transplantation Patients | We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liver Transplantation Patients | We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mmHg | From the time patients enter the operating room to leaving the operating room, up to 24 hours. | Measurements | Measurements |
|
From the time patients enter the operating room to leaving the operating room, up to 24 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liver Transplantation Patients | We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| YanYan Han | Cleveland Clinic Foundation | 216-444-2250 | HANY3@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2016 | Aug 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016031 | Liver Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 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. | From the time patients enter the operating room to leaving the operating room, up to 24 hours. |
| 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. | 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. | 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. | From the time patients enter the operating room to leaving the operating room, up to 24 hours. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Current smoker | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| ASA (American Society of Anesthesiologists) physical status | Count of Participants | Participants |
|
| Alcoholic Cirrhosis | Count of Participants | Participants |
|
| Primary Billary Cirrhosis | Count of Participants | Participants |
|
| Hepatocellular Carcinoma | Count of Participants | Participants |
|
| Primary Sclerosing Cholangitis | Count of Participants | Participants |
|
| Non-alcoholic Steatohepatosis (NASH) | Count of Participants | Participants |
|
| Viral Cirrhosis | Count of Participants | Participants |
|
We conducted a prospective, single-group, observational study in order to assess the correlation between the diameter of the superior vena cava (SVC) and the central venous pressure (CVP) in patients undergoing liver transplantation surgeries. Aside for the transthoracic echocardiogram necessary to measure the SVC, no additional treatments were applied to the patient population. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | index | From the time patients enter the operating room to leaving the operating room, up to 24 hours. | Measurements | Measurements |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mm | From the time patients enter the operating room to leaving the operating room, up to 24 hours. | Measurements | Measurements |
|
|
|
|
| Primary | 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. | maximum Superior Vena Cava (SVC) | Posted | Mean | Standard Deviation | mm | From the time patients enter the operating room to leaving the operating room, up to 24 hours. | Measurements | Measurements |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | L/min/m2 | From the time patients enter the operating room to leaving the operating room, up to 24 hours. | Measurements | Measurements |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | index | From the time patients enter the operating room to leaving the operating room, up to 24 hours. | Measurements | Measurements |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | From the time patients enter the operating room to leaving the operating room, up to 24 hours. | Measurements | Measurements |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | From the time patients enter the operating room to leaving the operating room, up to 24 hours. | Measurements | Measurements |
|
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
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| D013505 |
| Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |