Hemodynamic Measurements During Liver Transplantation

Liver Transplantation Clinical Trial

— OLT  

Official title:

Comparing Different Methods For Measurement of Cardiac Output During Orthotopic Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682110
• Other study ID #: 07-0042
• Status: Completed
• Phase: N/A
• First received: May 16, 2008
• Last updated: March 31, 2010
• Start date: July 2007
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Transplantation

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between cardiac output measurements obtained with PAC, Vigileo and LiDCO		Specific phases of liver transplantation surgery	No