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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01673230
First received: August 22, 2012
Last updated: August 25, 2014
Last verified: November 2013
  Purpose

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 Intervention
Ventricular Dysfunction
Procedure: cardiac surgery for ventricular dysfunction

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Measure of ∆PP, ∆POP, PVI and Cardiac index (CI) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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:
  • Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 80
Study Start Date: September 2012
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  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: 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
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01673230     History of Changes
Other Study ID Numbers: 2012-A00364-39, LOC/12-01
Study First Received: August 22, 2012
Last Updated: August 25, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014