NCT00682110

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 1, 2010

Status Verified

March 1, 2010

Enrollment Period

1.5 years

First QC Date

May 16, 2008

Last Update Submit

March 31, 2010

Conditions

Keywords

End-stage liver diseaseHemodynamic measurementsHyperdynamic circulationPulmonary artery catheterCardiac output

Outcome Measures

Primary Outcomes (1)

  • Agreement between cardiac output measurements obtained with PAC, Vigileo and LiDCO

    Specific phases of liver transplantation surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • Vannucci A, Burykin A, Krejci V, Peck T, Buchman TG, Kangrga IM. Postreperfusion cardiac arrest and resuscitation during orthotopic liver transplantation: dynamic visualization and analysis of physiologic recordings. Shock. 2012 Jan;37(1):34-8. doi: 10.1097/SHK.0b013e318239b128.

  • Krejci V, Vannucci A, Abbas A, Chapman W, Kangrga IM. Comparison of calibrated and uncalibrated arterial pressure-based cardiac output monitors during orthotopic liver transplantation. Liver Transpl. 2010 Jun;16(6):773-82. doi: 10.1002/lt.22056.

  • Vannucci A, Krejci V, Kangrga I. Performance of Vigileo and LiDCOplus cardiac output monitors during a prolonged cardiac arrest and resuscitation. Eur J Anaesthesiol. 2009 Oct;26(10):885-7. doi: 10.1097/EJA.0b013e32832fa5db. No abstract available.

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Ivan Kangrga, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 22, 2008

Study Start

July 1, 2007

Primary Completion

January 1, 2009

Study Completion

March 1, 2010

Last Updated

April 1, 2010

Record last verified: 2010-03

Locations