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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gulay ERDOGAN KAYHAN, Inonu University
ClinicalTrials.gov Identifier:
NCT01792011
First received: February 8, 2013
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Hemodynamic Instability
 Device: PVI-guided fluid management
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Inonu University:

Primary Outcome Measures:
  • To test the ability of PVI to detect changes in preload during orthotopic liver transplantation [ Time Frame: During dissection and anhepatic phase (3 months) ] [ Designated as safety issue: Yes ]
    PVI is a measure of the dynamic changes in perfusion index that occur during a complete respiratory cycle


Enrollment: 25
Study Start Date: October 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792011

Locations
Turkey
Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation
Malatya, Turkey, 44315
Sponsors and Collaborators
Inonu University
Investigators
Study Chair: Gulay Erdogan Kayhan, Dr Inonu University Faculty of Medicine Anesthesiology and Reanimation Department
  More Information

No publications provided

Responsible Party: Gulay ERDOGAN KAYHAN, MD,Asistant Professor Dr, Inonu University
ClinicalTrials.gov Identifier: NCT01792011     History of Changes
Other Study ID Numbers: Institute of LLT
Study First Received: February 8, 2013
Last Updated: February 13, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Inonu University:
Elective living donor liver transplantation

ClinicalTrials.gov processed this record on May 23, 2013