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

February 13, 2013 updated by: Gulay ERDOGAN KAYHAN, Inonu University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey, 44315
        • Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PVI
A new non-invasive device (Radical-7 pulse oximeter monitor, Masimo Corp.) has been introduced that continuously detects changes in the plethysmograph waveform and computes a Plethysmography Variability Index (PVI) reflecting alteration in preload and fluid management.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To test the ability of PVI to detect changes in preload during orthotopic liver transplantation
Time Frame: During dissection and anhepatic phase (3 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Study Chair: Gulay Erdogan Kayhan, Dr, Inonu University Faculty of Medicine Anesthesiology and Reanimation Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 8, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Institute of LLT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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