End Stage Liver DiseaseNCT00547924
Transoesophageal Echocardiography in Liver Transplantation
An observational study of End Stage Liver Disease, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Liver Disease
- What is being tested?
- Transoesophageal echocardiography
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2006to Jan 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on waiting list for liver transplantation
Who may be able to join
- Patients on waiting list for liver transplantation.
- Age: 18-75 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Institute for Anesthesiology
Zurich
About this study
Official title: Transoesophageal Echocardiography in Liver Transplantation: Left Ventricular Function During Reperfusion
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
- Conditions
- End Stage Liver Disease
- Being tested
- Transoesophageal echocardiography
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoesophageal echocardiographyBehavioural
Transoesophageal echocardiography in liver transplantation: left ventricular function during reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startApr 2006
- Primary completionJan 2010
- Study completionJan 2010
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 University of ZurichThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Zalunardo, MD, Principal investigator, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547924
- Sponsor's protocol ID
- StV 11-2006
- Status last verified
- Apr 2014
- First submitted
- 22 Oct 2007
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26209332
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoesophageal Echocardiography in Liver Transplantation: Left Ventricular Function During Reperfusion
- ClinicalTrials.gov ID
- NCT00547924
- Acronym / sponsor ID
- StV 11-2006
- Conditions
- End Stage Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Oct 2007 (estimated)
- 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.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on waiting list for liver transplantation
Key inclusion criteria (2 listed)
- Patients on waiting list for liver transplantation.
- Age: 18-75 years.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Transoesophageal echocardiographyTransoesophageal echocardiography in liver transplantation: left ventricular function during reperfusion | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
- Derived from this study: PubMed 26209332Zalunardo 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.
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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.
Marco Zalunardo, MD principal investigator
UniversitaetsSpital Zuerich
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, run by University of Zurich at 1 site in Switzerland.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 10 Apr 2014. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00547924, 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 10 Apr 2014.