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

NCT05457114 | Unknown

• 1 other identifier: H-2205-117-1327
• Study Type: observational
• Target: 1,970
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Liver DIsease; Liver Transplant; Complications; Liver Cirrhosis; Liver Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• In-hospital mortality

  the first month after admission

• One-year mortality

  one year after transplantation

• Length of intensive care unit (ICU) stay

  the first month after admission

• Length of hospital stay

  the first month after admission

Study Arms (2)

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)

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)

Interventions

Pulmonary artery catheter (Edward Lifesciences, Irvine, California, USA) DEVICE

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)

Pulmonary artery catheter group

FloTrac Vigileo system (EV1000 clinical platform, Edward Lifesciences, Irvine, California, USA) DEVICE

Without PAC, monitoring with FloTrac Vigileo system (EV1000 clinical platform, Edward Lifesciences, Irvine, California, USA) was performed for continuous cardiac output monitoring.

Non-pulmonary artery catheter group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (1)

• Jung JY, Sohn JY, Lim L, Cho H, Ju JW, Yoon HK, Yang SM, Lee HJ, Kim WH. Pulmonary artery catheter monitoring versus arterial waveform-based monitoring during liver transplantation: a retrospective cohort study. Sci Rep. 2023 Nov 15;13(1):19947. doi: 10.1038/s41598-023-46173-1.

  PMID: 37968287 DERIVED

MeSH Terms

Conditions

End Stage Liver Disease; Liver Cirrhosis; Liver Diseases

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Won Ho Kim, MD, PhD

  Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Ji-yoon Jung, MD

CONTACT

82-2-2072-2469; jiyooning1030@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2022
• First Posted: July 13, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)