End Stage Liver DIseaseNCT05457114
Association Between the Use of Pulmonary Artery Catheter and Clinical Outcomes After Liver Transplantation
An observational study of End Stage Liver DIsease and Liver Transplant; Complications, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End Stage Liver DIsease, Liver Transplant; Complications, Liver Cirrhosis
- What is being tested?
- Pulmonary artery catheter (Edward Lifesciences, Irvine, California, USA) and FloTrac Vigileo system (EV1000 clinical platform, Edward Lifesciences, Irvine, California, USA)
- Type of treatment
- Medical device
- How many people
- 1,970 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients received liver transplantation surgery in a single tertiary care university hospital
Who may be able to join
- Adult patients who underwent living or deceased donor liver transplantation at our tertiary care university hospital between 2006 and 2022
Who cannot join
- Patients with baseline renal dysfunction
- Missing baseline or outcome variables
- Retransplantation
- Patients who received intraoperative transesophageal echocardiography (TEE) monitoring
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Won Ho Kim, MD,PhD, 82-2-2072-3484 ext. 3484, wonhokim.ane@gmail.com
Ji-Yoon Jung, MD, 82-2-2072-2469 ext. 2469, jiyooning1030@gmail.com
About this study
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.
Read the 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.
- Being tested
- Pulmonary artery catheter (Edward Lifesciences, Irvine, California, USA), FloTrac Vigileo system (EV1000 clinical platform, Edward Lifesciences, Irvine, California, USA)
- Medical subject headings
- End Stage Liver Disease, Liver Cirrhosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary artery catheter group | Patients who received pulmonary artery catheter insertion and hemodynamic monitoring by PAC-derived parameters Receives: 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 Receives: Device: FloTrac Vigileo system (EV1000 clinical platform, Edward Lifesciences, Irvine, California, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: the first 7 postoperative days
Secondary outcomes (4)
In-hospital mortality
all-cause mortality during hospitalization
Measured: the first month after admission
One-year mortality
all-cause mortality during one year after transplantation
Measured: one year after transplantation
Length of intensive care unit (ICU) stay
Length of intensive care unit stay after transplantation
Measured: the first month after admission
Length of hospital stay
Length of hospital stay after transplantation
Measured: the first month after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 May 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,970 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, MD, Seoul National University Hospital
- Investigators
- Won Ho Kim, MD, PhD, Study chair, Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457114
- Sponsor's protocol ID
- H-2205-117-1327
- Status last verified
- Jul 2022
- First submitted
- 9 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37968287
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Use of Pulmonary Artery Catheter and Clinical Outcomes After Liver Transplantation
- ClinicalTrials.gov ID
- NCT05457114
- Acronym / sponsor ID
- H-2205-117-1327
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,970 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary artery catheter group | – | Device: Pulmonary artery catheter (Edward Lifesciences, Irvine, California, USA)Patients who received pulmonary artery catheter insertion and hemodynamic monitoring by PAC-derived parameters |
| Non-pulmonary artery catheter group | – | Device: FloTrac Vigileo system (EV1000 clinical platform, Edward Lifesciences, Irvine, California, USA)Patients who did not received pulmonary artery catheter insertion and were monitored with Flo-Trac FloTrac Vigileo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients received liver transplantation surgery in a single tertiary care university hospital
Key inclusion criteria (1 listed)
- Adult patients who underwent living or deceased donor liver transplantation at our tertiary care university hospital between 2006 and 2022
Key exclusion criteria (4 listed)
- Patients with baseline renal dysfunction
- Missing baseline or outcome variables
- Retransplantation
- Patients who received intraoperative transesophageal echocardiography (TEE) monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Pulmonary artery catheter group |
| 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. | Device | Non-pulmonary artery catheter group |
Primary outcome
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.
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
4 secondary outcomes
In-hospital mortality
Time frame: the first month after admission
One-year mortality
Time frame: one year after transplantation
Length of intensive care unit (ICU) stay
Time frame: the first month after admission
Length of hospital stay
Time frame: the first month after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Derived from this study: PubMed 37968287Jung 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.
- Individual participant dataSharing planned: No
Related trials for End Stage Liver DIsease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Ho Kim, MD, PhD study chair
Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Liver DIsease and Liver Transplant; Complications, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-yoon Jung, MD (82-2-2072-2469, jiyooning1030@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with acute kidney injury (time frame: the first 7 postoperative days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05457114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.