Clinical trial NCT00682110: Hemodynamic Measurements During Liver Transplantation
Official title: Comparing Different Methods For Measurement of Cardiac Output During Orthotopic Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Keywords: End-stage liver disease
Hemodynamic measurements
Hyperdynamic circulation
Pulmonary artery catheter
Cardiac output
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Agreement between cardiac output measurements obtained with PAC, Vigileo and LiDCO
timeFrame: Specific phases of liver transplantation surgery
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ivan Kangrga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.