Accuracy of the Pleth Variability Index to Predict Fluid Responsiveness in Liver Transplantation

Hemodynamic Instability Clinical Trial

Official title:

Accuracy and Utility of the Pleth Variability Index as a Predictor of Fluid Responsiveness During the Dissection and Anhepatic Phase of Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792011
• Other study ID #: Institute of LLT
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2013
• Last updated: February 13, 2013
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the accuracy of PVI (pleth variability index)

Description:

The aim of this study is to compare the accuracy of PVI (pleth variability index)with other hemodynamic variability that measured with PİCCO (SVV, PPV, CVP,CI)to predict the response of cardiac index to volume replacement in patients undergoing liver transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective living donor liver transplantation,

• >18 years patients

Exclusion Criteria:

Patients with:

• Arrhythmia

• Reduced left ventricular function (EF<40%)

• Hepatocellular carcinoma

• Pulmonary hypertension

• Fulminant liver failure

• valvular heart disease

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Device:
• PVI-guided fluid management
In this study of 25 adult patients undergoing OLT, we prospectively record PVIwithin 5 minutes during dissection and anhepatic phase of OLT by Masimo pulse oximeter.In this study of 25 adult patients undergoing OLT, we prospectively record study data within 5 minutes during dissection and anhepatic phase of OLT. Study data included measurements of PVI,thermodilution cardiac output, Stroke volume variation (SVV) and Pulse pressure variation (PPV).

Locations

Country	Name	City	State
Turkey	Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the ability of PVI to detect changes in preload during orthotopic liver transplantation	PVI is a measure of the dynamic changes in perfusion index that occur during a complete respiratory cycle	During dissection and anhepatic phase (3 months)	Yes