Atrial Fibrillation
Conditions
Keywords
landiolol, microcirculation, cardiac surgery, atrial fibrillation
Brief summary
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.
Interventions
DRUGLandiolol
Landiolol perfusion over 120 minutes in incremental doses : 0.5, 1, 2, 5 and 10 µg/kg/min. Doses are modified every 20 minutes
DRUGPlacebo
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient underwent conventional cardiac surgery * Age \> 18 years * Writing contentment
Exclusion criteria
* Pre-existing chronic atrial fibrillation * Contraindication to beta-blockers * Circulatory shock (cardiac index\<2.2 L/min and lactate\>4mmol/L) * Distributive shock (cardiac index\>2.2 L/min with norepinephrine dose \> 0.3 µg/kg/min to reach mean arterial pressure \> 65mmHg). * Acute respiratory distress * Major bleeding (\>200mL/h) * Patient already included into an interventional clinical study * Pregnancy * No social security insurance * Patient not able to give consent (curators, patients deprived of public rights)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS) | at 20 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of perfused vessels acquired by sublingual microscopy | at 120 minutes | — |
| functional capillary density acquired by sublingual microscopy | at 120 minutes | — |
| De Backer score acquired by sublingual microscopy | at 120 minutes | — |
| heterogeneity of the mean flow index acquired by sublingual microscopy | at 120 minutes | — |
| Heart rate | at 120 minutes | hemodynamic parameters |
| systolic arterial pressure | at 120 minutes | hemodynamic parameters |
| diastolic arterial pressure | at 120 minutes | hemodynamic parameters |
| cardiac output measured by transthoracic echocardiography | at 120 minutes | hemodynamic parameters |
| systemic vascular resistance | at 120 minutes | hemodynamic parameters |
| arterial elastance. | at 120 minutes | hemodynamic parameters |
| Microcirculatory mean flow index (MIF) acquired by sublingual microscopy | at 120 minutes | — |
| telesystolic volumes of the right ventricle | at 120 minutes | echocardiographic parameters |
| telesystolic volumes of the left ventricle | at 120 minutes | echocardiographic parameters |
| telediastolic volumes of the right ventricle | at 120 minutes | echocardiographic parameters |
| telediastolic volumes of the left ventricle | at 120 minutes | echocardiographic parameters |
| right ventricle contractility (measured with TAPSE and tricuspid S-wave) | at 120 minutes | echocardiographic parameters |
| intracardiac filling pressure profiles (E/a, E/Vp, E/e') | at 120 minutes | echocardiographic parameters |
| oxygen consumption (V02) | at 120 minutes | tissular perfusion parameters |
| oxygen delivery (DO2), | at 120 minutes | tissular perfusion parameters |
| carbon dioxide production (VCO2) | at 120 minutes | tissular perfusion parameters |
| arterial lactate | at 120 minutes | tissular perfusion parameters |
| Ejection fraction of the left ventricle (FEVG) | at 120 minutes | echocardiographic parameters |
Countries
France
Outcome results
None listed