LiverNCT00343122
Echocardiographic Assessment of Intrapulmonary Vasodilatation: Agitated Saline Versus Polygeline
An observational study of Liver and Cirrhosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of the study is to evaluate agitated saline versus polygeline for detection of intrapulmonary vasodilatation in patients with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- echocardiography for intrapulmonary vasodilatation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2006to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- presence of liver cirrhosis
- evaluation for liver transplantation or transjugular intrahepatic portosystemic shunt
Who cannot join
- inadequate echocardiographic image quality
- allergies to echocardiographic contrast agents
- pulmonary valve stenosis
- pulmonary embolism
- relevant tricuspid regurgitation
- cardiomyopathy
Trial locations and contacts
1 site in 1 country.
Peter Schenk, MD contact
Austria1 site, 1 recruiting
- Recruiting
Intensive Care Unit 13H1, Dep. of Internal Medicine IV, Medical University of Vienna
Vienna, State of Vienna, A-1090
Valentin Fuhrmann, MD, 0043-1-40400 ext. 4766, valentin.fuhrmann@meduniwien.ac.at
Peter Schenk, MD
About this study
Official title: Evaluation of Two Methods for the Echocardiographic Assessment of Intrapulmonary Vasodilatation in Patients With Liver Cirrhosis: Agitated Saline Versus Polygelatine
The purpose of the study is to evaluate agitated saline versus polygeline for detection of intrapulmonary vasodilatation in patients with cirrhosis.
Read the detailed description
Intrapulmonary vasodilatation is a frequent finding in patients with cirrhosis. Its diagnosis is established via contrast enhanced echocardiography. One used method is the contrast agent agitated saline and another frequently used method is the contrast agent polygeline. The purpose of this study is to compare these two echocardiographic contrast agents with respect to their ability to detect intrapulmonary vasodilatation.
- Being tested
- echocardiography for intrapulmonary vasodilatation
- Keywords
- liver, cirrhosis, hepatopulmonary syndrome
- Medical subject headings
- Fibrosis, Hepatopulmonary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography for intrapulmonary vasodilatationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startJun 2006
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 LiverStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Peter Schenk, MD, Principal investigator, Intensive Care Unit 13h1, Dep. of Internal Medicine IV, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343122
- Sponsor's protocol ID
- EK 4462005
- Status last verified
- Sep 2007
- First submitted
- 20 Jun 2006
- Last updated
- 17 Sep 2007
- Results posted
- No
Publications
Rodriguez-Roisin R, Krowka MJ, Herve P, Fallon MB; ERS Task Force Pulmonary-Hepatic Vascular Disorders (PHD) Scientific Committee. Pulmonary-Hepatic vascular Disorders (PHD). Eur Respir J. 2004 Nov;24(5):861-80. doi: 10.1183/09031936.04.00010904. No abstract available.
PubMed 15516683
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Methods for the Echocardiographic Assessment of Intrapulmonary Vasodilatation in Patients With Liver Cirrhosis: Agitated Saline Versus Polygelatine
- ClinicalTrials.gov ID
- NCT00343122
- Acronym / sponsor ID
- EK 4462005
- Keywords
- liver, cirrhosis, hepatopulmonary syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2006
- First posted
- 22 Jun 2006 (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.
The purpose of the study is to evaluate agitated saline versus polygeline for detection of intrapulmonary vasodilatation in patients with cirrhosis.
Detailed description
Intrapulmonary vasodilatation is a frequent finding in patients with cirrhosis. Its diagnosis is established via contrast enhanced echocardiography. One used method is the contrast agent agitated saline and another frequently used method is the contrast agent polygeline. The purpose of this study is to compare these two echocardiographic contrast agents with respect to their ability to detect intrapulmonary vasodilatation.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- presence of liver cirrhosis
- evaluation for liver transplantation or transjugular intrahepatic portosystemic shunt
Key exclusion criteria (6 listed)
- inadequate echocardiographic image quality
- allergies to echocardiographic contrast agents
- pulmonary valve stenosis
- pulmonary embolism
- relevant tricuspid regurgitation
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 |
|---|---|---|
| echocardiography for intrapulmonary vasodilatation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2007.
- Background: PubMed 15516683Rodriguez-Roisin R, Krowka MJ, Herve P, Fallon MB; ERS Task Force Pulmonary-Hepatic Vascular Disorders (PHD) Scientific Committee. Pulmonary-Hepatic vascular Disorders (PHD). Eur Respir J. 2004 Nov;24(5):861-80. doi: 10.1183/09031936.04.00010904. No abstract available.
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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.
Peter Schenk, MD contact
Peter Schenk, MD principal investigator
Intensive Care Unit 13h1, Dep. of Internal Medicine IV, Medical University of Vienna
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 and Cirrhosis, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 6 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 17 Sep 2007. 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 Austria. 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 Valentin Fuhrmann, MD (0043-1-40400 ext. 4766, valentin.fuhrmann@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00343122, 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 17 Sep 2007.