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Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%) (ALTERVOL)

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ClinicalTrials.gov Identifier: NCT01673230
Recruitment Status : Unknown
Verified September 2015 by Rennes University Hospital.
Recruitment status was:  Recruiting
First Posted : August 27, 2012
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not been showed until now when LVEF is altered.

Condition or disease Intervention/treatment Phase
Ventricular Dysfunction Procedure: cardiac surgery for ventricular dysfunction Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%): Sensibility and Specificity of Respiratory Variations of Pulse Pressure (∆PP), Photoplethysmography (∆POP), Perfusion Index (PVI), Before and After Fluid Expansion.
Study Start Date : September 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
Ventricular dysfunction
cardiac surgery for ventricular dysfunction
Procedure: cardiac surgery for ventricular dysfunction
For each included patient during the immediate post operative period, hemodynamic variables will be recorded (continuous arterial pressure, ECG, photoplethysmographic curve, CVP, wedge pressure, respiratory pressure), at rest (proclive 45°), during fluid expansion (physiological saline).



Primary Outcome Measures :
  1. Measure of ∆PP, ∆POP, PVI and Cardiac index (CI) [ Time Frame: 2 hours ]
    To assess the sensibility and specificity of ∆PP, ∆POP, PVI, after fluid expansion in case of hemodynamic failure in the immediate post-operative period after cardiac surgery, when pre-operative LVEF is altered.


Secondary Outcome Measures :
  1. Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure. [ Time Frame: 2 hours ]

    Secondary objectives :

    • Early optimization of hemodynamics after cardiac surgery,
    • To determine optimal threshold for ∆PP, ∆POP and PVI,
    • To compare dynamic (∆PP, ∆POP and PVI) with static (central venous pressure: CVP, wedge pressure) indices



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients >18 years old in the immediate post-operative period after cardiac surgery
  • ASA 1 - 3
  • Pre-operative LVEF≤45%
  • Sedated with Ramsay score: 6
  • Mechanically ventilated with tidal volume at 8ml/kg, PEEP at 0mmHg, I/Eat 0,5
  • With hemodynamic failure: SAP≤90mmHg and/or inotropic or vasoactive drug started in the operating room and/or clinical sign of shock and/or CI ≤2,3l/min/m2
  • Affiliation to Health Insurance
  • Consent form signed

Exclusion Criteria:

  • Cardiac arrhythmia: frequent atrial or ventricular extra systoles, atrial fibrillation
  • Intracardiac shunt
  • Weight less than 50 kg
  • History of central nervous system illness
  • Pulmonary oedema (clinical and/or radiological and/or wedge pressure>18mmHg)
  • Right ventricular failure suspected (CVP> wedge pressure) or diagnosed (trans thoracic and/or transesophageal echocardiography)
  • Acute kidney injury with oligoanuria
  • Severe post operative bleeding (chest tubes volume of >200ml/h for 3 hours or more)
  • Severe hypoxia (PaO2/FIO2< 100)
  • Administrative control (patient under guardianship or curatorship)

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): NCT01673230


Contacts
Contact: patrick guinet patrick.guinet@chu-rennes.fr

Locations
France
Rennes University Hospital Recruiting
Rennes, Brittany, France, 35033
Contact: patrick guinet       patrick.guinet@chu-rennes.fr   
Principal Investigator: patrick guinet         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: patrick guinet Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01673230     History of Changes
Other Study ID Numbers: 2012-A00364-39
LOC/12-01 ( Other Identifier: Rennes University Hospital (Direction of Clinical Research) )
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases