Prediction of Volume Responsiveness in Presence of Left Ventricular Diastolic Dysfunction

Study Overview
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Brief Summary
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The ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV) and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of left ventricular diastolic dysfunction is still unknown. The aim of the present study was to challenge the predictive power of GEDVI, SVV and PPV in cardiac surgery patients undergoing aortic valve replacement.

Detailed Description
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All patients receive premedication with midazolam 7.5 mg p.o.. After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O. Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter and a central venous catheter in the right or left internal jugular vein. Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction. In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany). Additionally capnography, urine output, temperature (blood, bladder and nasopharyngeal), airway pressure, and pulse oximetry are recorded. Before starting operation a passive leg raising is performed. The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and was performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size. In case of an increase of stroke volume index (SVI) >15% during PLR, patients were defined as responders. All patients were studied with no changes in anesthesia management. Measurements of SVI, GEDVI, SVV and PPV are performed before, during and after PLR. Thereafter, patients receive a fluid Bolus of 500 ml crystalloids. Again, measurements are performed before and after fluid replacement.

Official Title
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Prediction of Fluid Responsiveness in Presence of Diastolic Dysfunction

Conditions
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Hemodynamics

Intervention / Treatment
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* Other: passive leg raising
* Other: premedication
* Other: intubation and mechanical ventilation
* Other: central venous catheter
* Other: arterial catheter
* Other: transesophageal echocardiography
* Other: transpulmonary thermodilution catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 yrs of age Patients with a left ventricular ejection fraction ≥0.5 Patients with left ventricular diastolic dysfunction. Exclusion Criteria: Emergency procedures Right ventricular dysfunction Hemodynamic instability requiring pharmacologic Support Ongoing arrhythmia Intracardiac Shunts Severe mitral stenosis or insufficiency Aortic aneurysm > 4 cm Use of an artificial left ventricular assist device or intra - aortic balloon pump.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Passive leg raising<br> | Other: passive leg raising<br>* The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and is performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size.<br>|
| Other: premedication<br> | Other: premedication<br>* patients receive premedication with midazolam 7.5 mg p.o.<br>|
| Other: intubation and mechanical ventilation<br> | Other: intubation and mechanical ventilation<br>* After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O.<br>|
| Other: central venous catheter<br> | Other: central venous catheter<br>* a central venous catheter in the right or left internal jugular vein.<br>|
| Other: arterial catheter<br>Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter | Other: arterial catheter<br>* Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter<br>|
| Other: transesophageal echocardiography<br> | Other: transesophageal echocardiography<br>* Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction.<br>|
| Other: transpulmonary thermodilution catheter<br> | Other: transpulmonary thermodilution catheter<br>* In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in stroke volume index (SVI) >15% | In presence of an increase of SVI >15% during PLR and/or 500 ml crystalloids, patients are defined as responders. | Patients will be obtained until the end of the operation, an expected average of 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid responsiveness, diastolic dysfunction, left ventricular