NCT03459924

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 27, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

February 27, 2018

Last Update Submit

March 3, 2018

Conditions

Keywords

Right ventricular functionLiver transplantationTransesophageal echocardiography

Outcome Measures

Primary Outcomes (1)

  • Development of new right ventricular dysfunction during liver transplantation

    Signs of right ventricular dysfunction as assessed by transesophageal echocardiography

    Through study completion, after 1 year of data retrieval and analysis.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult cirrhotic patients who underwent a orthotopic liver transplantation

You may qualify if:

  • Adult patients who underwent orthotopic liver transplantation from april 2012 to april 2013.

You may not qualify if:

  • Pulmonary hypertension (any type)
  • Cardiopulmonary disease (eg: chronic obstructive pulmonary disease (COPD), valvular heart disease, ischemic heart disease)
  • Fulminant hepatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, 21941590, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 2660629BACKGROUND
  • De 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.

    PMID: 8452268BACKGROUND
  • Gouvea 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.

    PMID: 18534974BACKGROUND
  • Gouvea 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.

    PMID: 20381292BACKGROUND

Study Officials

  • Nubia V Figueiredo, MSc, PhD

    Universidade Federal do Rio de Janeiro

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 9, 2018

Study Start

February 27, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 9, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations