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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01792011
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gulay ERDOGAN KAYHAN, Inonu University
  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: Intervention Model: Single Group Assignment
Masking: Single (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:


Further study details as provided by Gulay ERDOGAN KAYHAN, 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) ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 8, 2013
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Gulay ERDOGAN KAYHAN, Inonu University:
Elective living donor liver transplantation