Association Between the Use of Pulmonary Artery Catheter and Clinical Outcomes After Liver Transplantation

July 13, 2022 updated by: Won Ho Kim, MD, Seoul National University Hospital
The investigators attempted to evaluate whether the use of PAC is associated with better clinical outcomes after liver transplantation compared with the case without PAC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pulmonary artery catheter (PAC) has been used for advanced hemodynamic monitoring during liver transplantation. However, recent advances in less invasive monitoring could provide continuous cardiac output monitoring by arterial waveform analysis. Using this technology, stroke volume variation (SVV) is monitored as a preload index. Calculated systemic vascular resistance (SVR) can be monitored if central venous pressure (CVP) is provided. Therefore, this less invasive form of hemodynamic monitoring may replace the PAC. The investigators attempted to evaluate whether the use of PAC is associated with better clinical outcomes after liver transplantation compared with the case without PAC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1970

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients received liver transplantation surgery in a single tertiary care university hospital

Description

Inclusion Criteria:

  • Adult patients who underwent living or deceased donor liver transplantation at our tertiary care university hospital between 2006 and 2022

Exclusion Criteria:

  • Patients with baseline renal dysfunction
  • Missing baseline or outcome variables
  • Retransplantation
  • Patients who received intraoperative transesophageal echocardiography (TEE) monitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Pulmonary artery catheter group
Patients who received pulmonary artery catheter insertion and hemodynamic monitoring by PAC-derived parameters
Device: Pulmonary artery catheter (Edward Lifesciences, Irvine, California, USA)
PAC was inserted and connected to a continuous cardiac output monitor (Vigilance I from 2006 to 2012; Vigilance II from 2012 to 2022, Edward Lifesciences, Irvine, USA)
Non-pulmonary artery catheter group
Patients who did not received pulmonary artery catheter insertion and were monitored with Flo-Trac FloTrac Vigileo
Device: FloTrac Vigileo system (EV1000 clinical platform, Edward Lifesciences, Irvine, California, USA)
Without PAC, monitoring with FloTrac Vigileo system (EV1000 clinical platform, Edward Lifesciences, Irvine, California, USA) was performed for continuous cardiac output monitoring.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with acute kidney injury
Time Frame: the first 7 postoperative days
Acute kidney injury (AKI) was defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria, which was defined according to the greatest change in serum creatinine level during the postoperative seven days (Stage 1: more than 1.5-fold; stage 2: more than 2-fold; stage 3: more than 3-fold increase from baseline level or increase in serum creatinine to ≥ 4.0 mg/dL or the initiation of renal replacement therapy). The most recent serum creatinine level measured before surgery was collected as a baseline value.
the first 7 postoperative days
Number of Participants with early allograft dysfunction
Time Frame: the first 7 postoperative days
Early allograft dysfunction (EAD) was defined when one or more of the following are present within the first 7 postoperative days: total bilirubin ≥ 10 mg/dL, prothrombin time: international normalized ratio ≥ 1.6, or aspartate or alanine transaminase > 2000 IU/L
the first 7 postoperative days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: the first month after admission
all-cause mortality during hospitalization
the first month after admission
One-year mortality
Time Frame: one year after transplantation
all-cause mortality during one year after transplantation
one year after transplantation
Length of hospital stay
Time Frame: the first month after admission
Length of hospital stay after transplantation
the first month after admission
Length of intensive care unit (ICU) stay
Time Frame: the first month after admission
Length of intensive care unit stay after transplantation
the first month after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-2205-117-1327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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