Echocardiographic Assessment of Intrapulmonary Vasodilata... | NCT00343122

Studies
Echocardiographic Assessment of Intrapulmonary Vasodilatation: Agitated Saline Versus Polygeline

NCT00343122

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Sep 17, 2007Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Liver
Cirrhosis

Interventions

echocardiography for intrapulmonary vasodilatation

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 20, 2006

First Submission Date that Met QC Criteria

Jun 20, 2006

First Posted Date

Jun 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2007

Last Update Posted Date

Sep 17, 2007Estimated

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
echocardiography for intrapulmonary vasodilatation	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years
presence of liver cirrhosis
evaluation for liver transplantation or transjugular intrahepatic portosystemic shunt

Exclusion Criteria:

inadequate echocardiographic image quality
allergies to echocardiographic contrast agents
pulmonary valve stenosis
pulmonary embolism
relevant tricuspid regurgitation
cardiomyopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Valentin Fuhrmann, MD	Contact	0043-1-40400	4766	valentin.fuhrmann@meduniwien.ac.at
Peter Schenk, MD	Contact	0043-1-40400	4766

Overall Officials

Name	Affiliation	Role
Peter Schenk, MD	Intensive Care Unit 13h1, Dep. of Internal Medicine IV, Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive Care Unit 13H1, Dep. of Internal Medicine IV, Medical University of Vienna	Recruiting	Vienna	State of Vienna	A-1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15516683	Background	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.

ID	Term
D005355	Fibrosis
D020065	Hepatopulmonary Syndrome

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008107	Liver Diseases
D004066	Digestive System Diseases