NCT01792011

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

4 months

First QC Date

February 8, 2013

Last Update Submit

February 13, 2013

Conditions

Hemodynamic Instability

Keywords

Elective living donor liver transplantation

Outcome Measures

Primary Outcomes (1)

  • To test the ability of PVI to detect changes in preload during orthotopic liver transplantation

    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)

Study Arms (1)

PVI

EXPERIMENTAL

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

Interventions

PVI-guided fluid managementDEVICE

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).

PVI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective living donor liver transplantation,
  • \>18 years patients

You may not qualify if:

  • Patients with:
  • Arrhythmia
  • Reduced left ventricular function (EF\<40%)
  • Hepatocellular carcinoma
  • Pulmonary hypertension
  • Fulminant liver failure
  • valvular heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation

Malatya, 44315, Turkey (Türkiye)

Location

Study Officials

  • Gulay Erdogan Kayhan, Dr

    Inonu University Faculty of Medicine Anesthesiology and Reanimation Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,Asistant Professor Dr

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 15, 2013

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

TU(1)