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

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: Recruiting
• Conditions: Liver Diseases; Liver Cirrhosis; Liver Transplant; Complications; End Stage Liver DIsease
• Intervention / Treatment: Device: Pulmonary artery catheter (Edward Lifesciences, Irvine, California, USA); Device: FloTrac Vigileo system (EV1000 clinical platform, Edward Lifesciences, Irvine, California, USA)

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: Observational
• Enrollment (Anticipated): 1970

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ji-Yoon Jung, MD; Phone Number: 2469 82-2-2072-2469; Email: jiyooning1030@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of Participants with acute kidney injury	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	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

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	all-cause mortality during hospitalization	the first month after admission
One-year mortality	all-cause mortality during one year after transplantation	one year after transplantation
Length of hospital stay	Length of hospital stay after transplantation	the first month after admission
Length of intensive care unit (ICU) stay	Length of intensive care unit stay after transplantation	the first month after admission

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 9, 2022
• First Submitted That Met QC Criteria: July 9, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Fibrosis; Liver Diseases; End Stage Liver Disease; Liver Cirrhosis
• Other Study ID 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