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

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ClinicalTrials.gov Identifier: NCT01792011
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Gulay ERDOGAN KAYHAN, Inonu University

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

Condition or disease Intervention/treatment Phase
Hemodynamic Instability Device: PVI-guided fluid management Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : October 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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Responsible Party: Gulay ERDOGAN KAYHAN, MD,Asistant Professor Dr, Inonu University
ClinicalTrials.gov Identifier: NCT01792011    
Other Study ID Numbers: Institute of LLT
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Gulay ERDOGAN KAYHAN, Inonu University:
Elective living donor liver transplantation