Hemodynamic Measurements During Liver Transplantation - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00682110

Purpose

The purpose of the study is to determine if the less invasive monitors are as reliable for measuring heart function in patients undergoing liver transplantation as the more invasive pulmonary artery.

Condition
Liver Transplantation

MedlinePlus related topics: Liver Transplantation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Comparing Different Methods For Measurement of Cardiac Output During Orthotopic Liver Transplantation

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Agreement between cardiac output measurements obtained with PAC, Vigileo and LiDCO [ Time Frame: Specific phases of liver transplantation surgery ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	July 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

Pulmonary artery catheter (PAC)is considered the gold standard in monitoring of heart function during orthotopic liver transplantation (OLT). Placement of PAC is very invasive (it passes thorough the heart chambers and into the pulmonary artery) and its benefits on the outcomes have not been proven. This study compares two newer FDA approved much less invasive devices to the PAC. The two new devices assess the heart function based either on the peripheral arterial waveform alone (Vigileo, Edwards Lifesciences)or the combination of peripheral arterial waveform and chemical indicator dilution (LiDCO, Cambridge, UK).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

20 subjects will be enrolled in this observational study in the Liver Transplant Group; 10 patients in the Other Surgery Control Group for a total of 30 subjects. Patients will be recruited from the Operating Room schedule. Written, informed consent will be obtained from each subject prior to surgery. All participants will be informed that they may decline to participate in, or withdraw from, the study at any time.

Criteria

Inclusion Criteria:

Patients over 18 years of age
Scheduled for liver transplantation
Patient undergoing vascular surgery where invasive arterial pressure is indicated (control subjects)

Exclusion Criteria:

We will exclude patients taking lithium based medication
Patients who weigh less than 40 kg; AND
Patients who are pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682110

Contacts

Contact: Alhan Abbas, MD	314-747-3752	abbas@anest.wustl.edu
Contact: Ivan Kangrga, MD, PhD	314-747-2858	kangrgai@wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Ivan Kangrga, MD, PhD 314-747-2858 kangrgai@wustl.edu

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Ivan Kangrga, MD, PhD

Washington University School of Medicine

More Information

Responsible Party:	Professor of Anesthesiology ( Ivan Kangrga, MD, PhD )
Study ID Numbers:	07-0042
Study First Received:	May 16, 2008
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00682110
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

End-stage liver disease
Hemodynamic measurements
Hyperdynamic circulation
Pulmonary artery catheter
Cardiac output

Study placed in the following topic categories:

Liver Diseases

ClinicalTrials.gov processed this record on January 16, 2009