NCT02818218

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

April 11, 2016

Results QC Date

July 3, 2024

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

Secondary Outcomes (4)

  • Cardiac Index

    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

    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)

    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)

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

Interventions

liver transplant recipient surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Contraindication to Transesophageal echocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Liver Failure

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Results Point of Contact

Title
YanYan Han
Organization
Cleveland Clinic Foundation

Study Officials

  • Daniel Sessler

    Outcomes Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2016

First Posted

June 29, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2019

Study Completion

September 1, 2020

Last Updated

August 7, 2025

Results First Posted

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations