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NCT Number: NCT01673230

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%)

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.

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Key information

Conditions

Ventricular Dysfunction Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cardiac surgery for ventricular dysfunction

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study 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.

Acronym: ALTERVOL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2012
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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