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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000307-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Landiolol group | Experimental | Landiolol perfusion in incremental doses (range 0.5 to 10 µg/kg/min) over 2 hours |
|
| Placebo group | Placebo Comparator | Placebo perfusion in incremental doses (range 0.03 to 0.6 mL/kg/h) over 2 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Landiolol | Drug | Landiolol perfusion over 120 minutes in incremental doses : 0.5, 1, 2, 5 and 10 µg/kg/min. Doses are modified every 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Microcirculatory mean flow index (MIF) acquired by sublingual microscopy | at 120 minutes | |
| proportion of perfused vessels acquired by sublingual microscopy | at 120 minutes | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Jacquet-Lagrèze | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Pradel | Bron | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33902917 | Result | Ferraris A, Jacquet-Lagreze M, Cazenave L, Fornier W, Jalalzai W, Rousseau-Saine N, Allaouchiche B, Junot S, Pozzi M, Fellahi JL; Anesthesie-Reanimation Coeur-Thorax-Vaisseaux (ARCOTHOVA) Group. Microcirculatory effects of landiolol: a double-blind, randomised, controlled study after cardiac surgery. Br J Anaesth. 2021 Jun;126(6):e212-e214. doi: 10.1016/j.bja.2021.03.013. Epub 2021 Apr 24. No abstract available. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C077049 | landiolol |
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| Placebo | Drug | 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. |
|
| 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. | 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 | hemodynamic parameters | at 120 minutes |
| systolic arterial pressure | hemodynamic parameters | at 120 minutes |
| diastolic arterial pressure | hemodynamic parameters | at 120 minutes |
| cardiac output measured by transthoracic echocardiography | hemodynamic parameters | at 120 minutes |
| systemic vascular resistance | hemodynamic parameters | at 120 minutes |
| arterial elastance. | hemodynamic parameters | at 120 minutes |
| Ejection fraction of the left ventricle (FEVG) | echocardiographic parameters | at 120 minutes |
| telesystolic volumes of the right ventricle | echocardiographic parameters | at 120 minutes |
| telesystolic volumes of the left ventricle | echocardiographic parameters | at 120 minutes |
| telediastolic volumes of the right ventricle | echocardiographic parameters | at 120 minutes |
| telediastolic volumes of the left ventricle | echocardiographic parameters | at 120 minutes |
| right ventricle contractility (measured with TAPSE and tricuspid S-wave) | echocardiographic parameters | at 120 minutes |
| intracardiac filling pressure profiles (E/a, E/Vp, E/e') | echocardiographic parameters | at 120 minutes |
| oxygen consumption (V02) | tissular perfusion parameters | at 120 minutes |
| oxygen delivery (DO2), | tissular perfusion parameters | at 120 minutes |
| carbon dioxide production (VCO2) | tissular perfusion parameters | at 120 minutes |
| arterial lactate | tissular perfusion parameters | at 120 minutes |
| D013568 |
| Pathological Conditions, Signs and Symptoms |