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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05457114
• Other study ID #: H-2205-117-1327
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Seoul National University Hospital
• Contact: Ji-yoon Jung, MD
• Phone: 82-2-2072-2469
• Email: jiyooning1030[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1970
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	In-hospital mortality	all-cause mortality during hospitalization	the first month after admission
Secondary	One-year mortality	all-cause mortality during one year after transplantation	one year after transplantation
Secondary	Length of intensive care unit (ICU) stay	Length of intensive care unit stay after transplantation	the first month after admission
Secondary	Length of hospital stay	Length of hospital stay after transplantation	the first month after admission