Hemodynamic Measurements During Liver Transplantation (OLT)

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00682110
First received: May 16, 2008
Last updated: March 31, 2010
Last verified: March 2010
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 30
Study Start Date: July 2007
Study Completion Date: March 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Ivan Kangrga, MD, PhD Washington University School of Medicine
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ivan Kangrga, MD, PhD, Professor of Anesthesiology
ClinicalTrials.gov Identifier: NCT00682110     History of Changes
Other Study ID Numbers: 07-0042
Study First Received: May 16, 2008
Last Updated: March 31, 2010
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

ClinicalTrials.gov processed this record on October 01, 2014