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

February 8, 2013
February 13, 2013
October 2012
February 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01792011 on ClinicalTrials.gov Archive Site
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Accuracy of the Pleth Variability Index to Predict Fluid Responsiveness in Liver Transplantation
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)

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Hemodynamic Instability
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).
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.
Intervention: Device: PVI-guided fluid management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01792011
Institute of LLT
Yes
Gulay ERDOGAN KAYHAN, Inonu University
Inonu University
Not Provided
Study Chair: Gulay Erdogan Kayhan, Dr Inonu University Faculty of Medicine Anesthesiology and Reanimation Department
Inonu University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP