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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05457114
• Collaborator: (none)
• Enrollment: 1,970
• Location: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 245.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Liver DIsease; Liver Transplant; Complications; Liver Cirrhosis; Liver Diseases	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 Design

• Study Type: Observational
• Anticipated Enrollment: 1970 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Association Between the Use of Pulmonary Artery Catheter and Clinical Outcomes After Liver Transplantation
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants with acute kidney injury [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.

2. Number of Participants with early allograft dysfunction [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

Secondary Outcome Measures

1. In-hospital mortality [the first month after admission]

   all-cause mortality during hospitalization

2. One-year mortality [one year after transplantation]

   all-cause mortality during one year after transplantation

3. Length of intensive care unit (ICU) stay [the first month after admission]

   Length of intensive care unit stay after transplantation

4. Length of hospital stay [the first month after admission]

   Length of hospital stay after transplantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Study Chair: Won Ho Kim, MD, PhD, Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Won Ho Kim, MD, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT05457114
• Other Study ID Numbers: H-2205-117-1327
• First Posted: Jul 13, 2022
• Last Update Posted: Jul 15, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Liver Cirrhosis; End Stage Liver Disease

Study Results

No Results Posted as of Jul 15, 2022