NCT00547924

Brief Summary

Severe hypotension during reperfusion in liver transplantation is a frequent adverse event. Rare data exist so far about pathophysiology of this phenomenon. The exact role of left ventricular function, which might be impaired causing hypotension, has not been elucidated during the period of reperfusion. Goal of this study is to:

  • perform transesophageal echocardiography in order to assess systolic and diastolic left ventricular function during reperfusion
  • determine inflammatory mediators in the plasma which could cause left ventricular dysfunction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

3.8 years

First QC Date

October 22, 2007

Last Update Submit

April 9, 2014

Conditions

End Stage Liver Disease

Interventions

Transoesophageal echocardiographyBEHAVIORAL

Transoesophageal echocardiography in liver transplantation: left ventricular function during reperfusion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients on waiting list for liver transplantation

You may qualify if:

  • Patients on waiting list for liver transplantation.
  • Age: 18-75 years.

You may not qualify if:

  • Strictures, tumours and diverticula of the oesophagus.
  • History of oesophageal varices with recent bleeding.
  • Oesophageal varices and prothrombin time less than 20% or platetlets les than 30000/ml.
  • Instable cervical spine.
  • Involvement in other studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Institute for Anesthesiology

Zurich, Switzerland

Location

Related Publications (1)

  • Zalunardo MP, Schlapfer M, Beck-Schimmer B, Seifert B, Spahn DR, Bettex D. Impact of cytokine release on ventricular function after hepatic reperfusion: a prospective observational echocardiographic study with tissue Doppler imaging. BMC Anesthesiol. 2015 Jul 25;15:107. doi: 10.1186/s12871-015-0080-2.

    PMID: 26209332DERIVED

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Marco Zalunardo, MD

    UniversitaetsSpital Zuerich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 23, 2007

Study Start

April 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

April 10, 2014

Record last verified: 2014-04

Locations

CH(1)