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Preload Dependency by Impedance Cardiography After Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02132871
First received: May 5, 2014
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Cardiac Surgery With Extracorporeal Circulation
Device: Impedance cardiography Physioflow ®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Assessment of Preload Dependency by Passive Leg Raising Test and Impedance Cardiography Compared to Echocardiographic Measurements After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Area under ROC curve comparing SV variation (impedance cardiography) and VTI variation after PLR [ Time Frame: Within the 6 first hours after cardiac surgery ] [ Designated as safety issue: No ]
    Patients classified as responders and non responders to PLR : VTI variation ≥ 12% or < 12%


Secondary Outcome Measures:
  • Variation of central veinous pressure, left auricular pressure and left ventricular filling pressures after PLR (ROC curves, correlation tests) [ Time Frame: Within the 6 first hours after cardiac surgery ] [ Designated as safety issue: No ]
  • Respiratory variation of inferior vena cava [ Time Frame: Within the 6 first hours after cardiac surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Device: Impedance cardiography Physioflow ®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients requiring cardiac surgery

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02132871

Contacts
Contact: Nassim HESHMATI, MD 33.3.69.55.16.21 nassim.heshmati@chru-strasbourg.fr
Contact: Sandrine MARGUERITE, MD 33.3.69.55.16.30 sandrine.marguerite@chru-strasbourg.fr

Locations
France
Service d'Anesthésiologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Nassim HESHMATI, MD    33.3.69.55.16.21    nassim.heshmati@chru-strasbourg.fr   
Contact: Sandrine MARGUERITE, MD    33.3.69.55.16.30    sandrine.marguerite@chru-strasbourg.fr   
Sub-Investigator: Sandrine MARGUERITE, MD         
Sub-Investigator: Jean-Claude THIRANOS, MD         
Sub-Investigator: Mircea CRISTINAR, MD         
Sub-Investigator: Gharib AJOB, MD         
Sub-Investigator: Annick STEIB, MD         
Sub-Investigator: Paul-Michel MERTES, MD         
Principal Investigator: Nassim HESHMATI, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Nassim HESHMATI, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02132871     History of Changes
Other Study ID Numbers: 5516
Study First Received: May 5, 2014
Last Updated: November 10, 2014
Health Authority: FRANCE : Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé (CCTIRS)
FRANCE : Commission Nationale de l'Informatique et des Libertés (CNIL)

ClinicalTrials.gov processed this record on November 24, 2014