Liver Transplant; ComplicationsNCT03459924
Right Ventricular Function During Liver Transplantation as Assessed by Transesophageal Echocardiography.
An observational study of Liver Transplant; Complications, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
Cirrhotic patients undergoing liver transplantation might develop acute transient right ventricular dysfunction, ranging from mild to severe form. More than two decades ago, a number of studies with pulmonary artery catheters looked at this particular issue with controversial results. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant; Complications
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Feb 2018to 1 Jan 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cirrhotic patients who underwent a orthotopic liver transplantation
Who may be able to join
- Adult patients who underwent orthotopic liver transplantation from april 2012 to april 2013.
Who cannot join
- Pulmonary hypertension (any type)
- Cardiopulmonary disease (eg: chronic obstructive pulmonary disease (COPD), valvular heart disease, ischemic heart disease)
- Fulminant hepatitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Evaluation of Right Ventricular Function During Liver Transplantation: a Quantitative Analysis Using Transesophageal Echocardiography
Cirrhotic patients undergoing liver transplantation might develop acute transient right ventricular dysfunction, ranging from mild to severe form. More than two decades ago, a number of studies with pulmonary artery catheters looked at this particular issue with controversial results. However, the pulmonary artery catheter as a monitor for right ventricular function (RVF) has several limitations, while the echocardiogram is deemed to be more accurate in this regard. Therefore, we sought to evaluate the RVF with the transesophageal echocardiogram, and particularly whether the RVF significantly varies during this procedure.
Read the detailed description
Evaluation of right ventricular function (RVF) during orthotopic liver transplantation (OLT) has been extensively reported with modified pulmonary artery catheters that measure the right ventricular ejection fraction. However, quantitative analysis of RVF using transesophageal echocardiography (TEE) are scarce in this setting.
Methods: Nineteen cirrhotic patients who underwent OLT from April-2012 to April-2013 will be studied. Analysis of echocardiogram-derived parameters routinely used to evaluate ventricular function will be done. In particular, the RVF was quantitatively assessed by two parameters derived from TEE: tricuspid annular plane systolic excursion (TAPSE) and right ventricular fractional area change (RVFAC). Exclusion criteria: pulmonary hypertension, fulminant hepatitis, age less than 18 or greater than 65 years old and cardiopulmonary diseases. All echocardiographic and hemodynamic data set have been collected at 5 stages during the procedure, according to Institutional Protocol: baseline, hepatectomy, anhepatic phase, post-reperfusion, and closure.
Statistical Analysis: One-way ANOVA for repeated measurements will be used if the data have normal distribution, otherwise Friedman test will be used. P<0.05 is to be considered significant.
- Conditions
- Liver Transplant; Complications
- Keywords
- Right ventricular function, Liver transplantation, Transesophageal echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of new right ventricular dysfunction during liver transplantation
Signs of right ventricular dysfunction as assessed by transesophageal echocardiography
Measured: Through study completion, after 1 year of data retrieval and analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start27 Feb 2018
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, GLAUBER GOUVEA, Universidade Federal do Rio de Janeiro
- Investigators
- Nubia V Figueiredo, MSc, PhD, Study chair, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459924
- Sponsor's protocol ID
- 79763817.9.0000.5257
- Status last verified
- Mar 2018
- First submitted
- 27 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ellis JE, Lichtor JL, Feinstein SB, Chung MR, Polk SL, Broelsch C, Emond J, Thistlethwaite JR, Roizen MF. Right heart dysfunction, pulmonary embolism, and paradoxical embolization during liver transplantation. A transesophageal two-dimensional echocardiographic study. Anesth Analg. 1989 Jun;68(6):777-82.
PubMed 2660629De Wolf AM, Begliomini B, Gasior TA, Kang Y, Pinsky MR. Right ventricular function during orthotopic liver transplantation. Anesth Analg. 1993 Mar;76(3):562-8. doi: 10.1213/00000539-199303000-00020.
PubMed 8452268Gouvea G, Diaz R, Auler L, Martinho JM. Evaluation of the right ventricular ejection fraction during orthotopic liver transplantation under propofol anaesthesia. Br J Anaesth. 2008 Aug;101(2):161-5. doi: 10.1093/bja/aen145. Epub 2008 Jun 4.
PubMed 18534974Gouvea G, Diaz R, Auler L, Toledo R, Martinho JM. Right ventricular ejection fraction during orthotopic liver transplantation: does anesthetic technique make a difference? J Crit Care. 2010 Dec;25(4):657.e1-6. doi: 10.1016/j.jcrc.2010.02.005. Epub 2010 Apr 8.
PubMed 20381292
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Evaluation of Right Ventricular Function During Liver Transplantation: a Quantitative Analysis Using Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT03459924
- Acronym / sponsor ID
- 79763817.9.0000.5257
- Conditions
- Liver Transplant; Complications
- Keywords
- Right ventricular function, Liver transplantation, Transesophageal echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 9 Mar 2018 (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.
Cirrhotic patients undergoing liver transplantation might develop acute transient right ventricular dysfunction, ranging from mild to severe form. More than two decades ago, a number of studies with pulmonary artery catheters looked at this particular issue with controversial results. However, the pulmonary artery catheter as a monitor for right ventricular function (RVF) has several limitations, while the echocardiogram is deemed to be more accurate in this regard. Therefore, we sought to evaluate the RVF with the transesophageal echocardiogram, and particularly whether the RVF significantly varies during this procedure.
Detailed description
Evaluation of right ventricular function (RVF) during orthotopic liver transplantation (OLT) has been extensively reported with modified pulmonary artery catheters that measure the right ventricular ejection fraction. However, quantitative analysis of RVF using transesophageal echocardiography (TEE) are scarce in this setting.
Methods: Nineteen cirrhotic patients who underwent OLT from April-2012 to April-2013 will be studied. Analysis of echocardiogram-derived parameters routinely used to evaluate ventricular function will be done. In particular, the RVF was quantitatively assessed by two parameters derived from TEE: tricuspid annular plane systolic excursion (TAPSE) and right ventricular fractional area change (RVFAC). Exclusion criteria: pulmonary hypertension, fulminant hepatitis, age less than 18 or greater than 65 years old and cardiopulmonary diseases. All echocardiographic and hemodynamic data set have been collected at 5 stages during the procedure, according to Institutional Protocol: baseline, hepatectomy, anhepatic phase, post-reperfusion, and closure.
Statistical Analysis: One-way ANOVA for repeated measurements will be used if the data have normal distribution, otherwise Friedman test will be used. P<0.05 is to be considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cirrhotic patients who underwent a orthotopic liver transplantation
Key inclusion criteria (1 listed)
- Adult patients who underwent orthotopic liver transplantation from april 2012 to april 2013.
Key exclusion criteria (3 listed)
- Pulmonary hypertension (any type)
- Cardiopulmonary disease (eg: chronic obstructive pulmonary disease (COPD), valvular heart disease, ischemic heart disease)
- Fulminant hepatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of new right ventricular dysfunction during liver transplantation
Time frame: Through study completion, after 1 year of data retrieval and analysis.
Signs of right ventricular dysfunction as assessed by transesophageal echocardiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Background: PubMed 2660629Ellis JE, Lichtor JL, Feinstein SB, Chung MR, Polk SL, Broelsch C, Emond J, Thistlethwaite JR, Roizen MF. Right heart dysfunction, pulmonary embolism, and paradoxical embolization during liver transplantation. A transesophageal two-dimensional echocardiographic study. Anesth Analg. 1989 Jun;68(6):777-82.
- Background: PubMed 8452268De Wolf AM, Begliomini B, Gasior TA, Kang Y, Pinsky MR. Right ventricular function during orthotopic liver transplantation. Anesth Analg. 1993 Mar;76(3):562-8. doi: 10.1213/00000539-199303000-00020.
- Background: PubMed 18534974Gouvea G, Diaz R, Auler L, Martinho JM. Evaluation of the right ventricular ejection fraction during orthotopic liver transplantation under propofol anaesthesia. Br J Anaesth. 2008 Aug;101(2):161-5. doi: 10.1093/bja/aen145. Epub 2008 Jun 4.
- Background: PubMed 20381292Gouvea G, Diaz R, Auler L, Toledo R, Martinho JM. Right ventricular ejection fraction during orthotopic liver transplantation: does anesthetic technique make a difference? J Crit Care. 2010 Dec;25(4):657.e1-6. doi: 10.1016/j.jcrc.2010.02.005. Epub 2010 Apr 8.
- Individual participant dataSharing planned: No
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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.
Nubia V Figueiredo, MSc, PhD study chair
Universidade Federal do Rio de Janeiro
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 Liver Transplant; Complications, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 3 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 9 Mar 2018. 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 Brazil. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of new right ventricular dysfunction during liver transplantation (time frame: Through study completion, after 1 year of data retrieval and analysis.). 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 NCT03459924, which also lists 4 linked publications.
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 9 Mar 2018.