Postoperative atrial fibrillation is a common complication after cardiac surgery and is associated with an elevation of morbidity and mortality. The recommended treatment includes heart rate control with a beta blocker. Landiolol is a new-generation beta-blocker with favourable pharmacologic properties making an interesting drug to treat postoperative atrial fibrillation. However, Landiolol micro and macrocirculatory effects in the setting of atrial fibrillation are yet to describe. The aim of this study is to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo. Our hypothesis is Landiolol will improve microcirculation disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
Landiolol perfusion over 120 minutes in incremental doses : 0.5, 1, 2, 5 and 10 µg/kg/min. Doses are modified every 20 minutes
Placebo perfusion is sodium chloride NaCl 0.9% over 120 minutes in incremental doses : 0.03, 0.06, 0.12, 0.3 and 0.6 mL/kg/h. Doses are modified every 20 minutes. Perfusion are similar in landiolol group to preserve blind.
Hôpital Louis Pradel
Bron, France
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Time frame: at 20 minutes
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Time frame: at 40 minutes
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Time frame: at 60 minutes
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Time frame: at 80 minutes
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Time frame: at 100 minutes
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Time frame: at 120 minutes
Microcirculatory mean flow index (MIF) acquired by sublingual microscopy
Time frame: at 120 minutes
proportion of perfused vessels acquired by sublingual microscopy
Time frame: at 120 minutes
functional capillary density acquired by sublingual microscopy
Time frame: at 120 minutes
De Backer score acquired by sublingual microscopy
Time frame: at 120 minutes
heterogeneity of the mean flow index acquired by sublingual microscopy
Time frame: at 120 minutes
Heart rate
hemodynamic parameters
Time frame: at 120 minutes
systolic arterial pressure
hemodynamic parameters
Time frame: at 120 minutes
diastolic arterial pressure
hemodynamic parameters
Time frame: at 120 minutes
cardiac output measured by transthoracic echocardiography
hemodynamic parameters
Time frame: at 120 minutes
systemic vascular resistance
hemodynamic parameters
Time frame: at 120 minutes
arterial elastance.
hemodynamic parameters
Time frame: at 120 minutes
Ejection fraction of the left ventricle (FEVG)
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echocardiographic parameters
Time frame: at 120 minutes
telesystolic volumes of the right ventricle
echocardiographic parameters
Time frame: at 120 minutes
telesystolic volumes of the left ventricle
echocardiographic parameters
Time frame: at 120 minutes
telediastolic volumes of the right ventricle
echocardiographic parameters
Time frame: at 120 minutes
telediastolic volumes of the left ventricle
echocardiographic parameters
Time frame: at 120 minutes
right ventricle contractility (measured with TAPSE and tricuspid S-wave)
echocardiographic parameters
Time frame: at 120 minutes
intracardiac filling pressure profiles (E/a, E/Vp, E/e')
echocardiographic parameters
Time frame: at 120 minutes
oxygen consumption (V02)
tissular perfusion parameters
Time frame: at 120 minutes
oxygen delivery (DO2),
tissular perfusion parameters
Time frame: at 120 minutes
carbon dioxide production (VCO2)
tissular perfusion parameters
Time frame: at 120 minutes
arterial lactate
tissular perfusion parameters
Time frame: at 120 minutes