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Clinical Trials/NCT02132871
NCT02132871
Completed
Not Applicable

Noninvasive Assessment of Preload Dependency by Passive Leg Raising Test and Impedance Cardiography Compared to Echocardiographic Measurements After Cardiac Surgery

University Hospital, Strasbourg, France1 site in 1 country65 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery With Extracorporeal Circulation
Sponsor
University Hospital, Strasbourg, France
Enrollment
65
Locations
1
Primary Endpoint
Area under ROC curve comparing SV variation (impedance cardiography) and VTI variation after PLR
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The primary purpose of this study is to investigate wether the measure of stroke volume (SV) variations by impedance cardiography during passive leg raising (PLR) can reliably predict preload dependency after cardiac surgery, in comparison to a reference parameter : velocity time integral (VTI) variation measured by transthoracical echocardiography.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Men or women over 18 years
  • Affiliated to a social protection
  • Signed written consent
  • Informed about the results of the medical visit
  • All type of cardiac surgery with extracorporeal circulation performed at University Hospital of Strasbourg
  • Sedated and under mechanical ventilation

Exclusion Criteria

  • Cardiac arrhythmia
  • Contraindication to PLR maneuver
  • Exclusion period due to inclusion in a previous or ongoing study
  • Impossibility to provide enlightened information
  • Patient deprived of liberty, under judicial protection, trusteeship or guardianship
  • Pregnancy, lactation

Outcomes

Primary Outcomes

Area under ROC curve comparing SV variation (impedance cardiography) and VTI variation after PLR

Time Frame: Within the 6 first hours after cardiac surgery

Patients classified as responders and non responders to PLR : VTI variation ≥ 12% or \< 12%

Secondary Outcomes

  • Variation of central veinous pressure, left auricular pressure and left ventricular filling pressures after PLR (ROC curves, correlation tests)(Within the 6 first hours after cardiac surgery)
  • Respiratory variation of inferior vena cava(Within the 6 first hours after cardiac surgery)

Study Sites (1)

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