Trial Outcomes & Findings for Superior Vena Cava and Its Relationship to Central Venous Pressure Measurements in Liver Transplantation (NCT NCT02818218)

NCT ID: NCT02818218

Last Updated: 2025-08-07

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

58 participants

Primary outcome timeframe

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

Results posted on

2025-08-07

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
58
Overall Study
COMPLETED
58
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Liver Transplantation Patients
n=58 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.
Age, Continuous
60 years
n=5 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
Sex: Female, Male
Male
41 Participants
n=5 Participants
Race/Ethnicity, Customized
White
48 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
10 Participants
n=5 Participants
Current smoker
26 Participants
n=5 Participants
BMI
29 kg/m2
STANDARD_DEVIATION 6 • n=5 Participants
ASA (American Society of Anesthesiologists) physical status
3 (Severe systemic illness)
3 Participants
n=5 Participants
ASA (American Society of Anesthesiologists) physical status
4 (Life-threatening systemic illness)
53 Participants
n=5 Participants
ASA (American Society of Anesthesiologists) physical status
5 (Not expected to survive without the operation)
2 Participants
n=5 Participants
Alcoholic Cirrhosis
18 Participants
n=5 Participants
Primary Billary Cirrhosis
1 Participants
n=5 Participants
Hepatocellular Carcinoma
17 Participants
n=5 Participants
Primary Sclerosing Cholangitis
7 Participants
n=5 Participants
Non-alcoholic Steatohepatosis (NASH)
39 Participants
n=5 Participants
Viral Cirrhosis
16 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Liver Transplantation Patients
n=275 Measurements
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.
Central Venous Pressure (CVP)
11.7 mmHg
Standard Deviation 4.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Liver Transplantation Patients
n=269 Measurements
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.
Correlation of Central Venous Pressure (CVP) and Superior Vena Cava (SVC) Collapsibility Index
26 index
Standard Deviation 11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Liver Transplantation Patients
n=269 Measurements
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.
Correlation of Central Venous Pressure (CVP) and Minimum Diameter of Superior Vena Cava (SVC)
12.8 mm
Standard Deviation 3.1

PRIMARY outcome

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

Population: maximum 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.

Outcome measures

Outcome measures
Measure
Liver Transplantation Patients
n=269 Measurements
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.
Correlation of Central Venous Pressure (CVP) and Maximum Diameter of Superior Vena Cava (SVC)
17.3 mm
Standard Deviation 3.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Liver Transplantation Patients
n=269 Measurements
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.
Cardiac Index
4.4 L/min/m2
Standard Deviation 1.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Liver Transplantation Patients
n=269 Measurements
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.
Correlation of Cardiac Index (CI) and Superior Vena Cava (SVC) Collapsibility Index
26 index
Standard Deviation 11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Liver Transplantation Patients
n=269 Measurements
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.
Correlation of Cardiac Index (CI) and Minimum Diameter of Superior Vena Cava (SVC)
12.8 mm
Standard Deviation 3.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Liver Transplantation Patients
n=269 Measurements
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.
Correlation of Cardiac Index (CI) and Maximum Diameter of Superior Vena Cava (SVC)
17.3 mm
Standard Deviation 3.2

Adverse Events

Liver Transplantation Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

YanYan Han

Cleveland Clinic Foundation

Phone: 216-444-2250

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place