Clinical trial NCT03779178: Landiolol in Postoperative Atrial Fibrillation
Official title: Microcirculatory and Macrocirculatory Effects of Landiolol in Prevention of Postoperative Atrial Fibrillation: a Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: landiolol
microcirculation
cardiac surgery
atrial fibrillation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
timeFrame: at 20 minutes
measure: Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
timeFrame: at 40 minutes
measure: Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
timeFrame: at 60 minutes
measure: Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
timeFrame: at 80 minutes
measure: Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
timeFrame: at 100 minutes
measure: Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
timeFrame: at 120 minutes
Secondary outcomes:
measure: Microcirculatory mean flow index (MIF) acquired by sublingual microscopy
timeFrame: at 120 minutes
measure: proportion of perfused vessels acquired by sublingual microscopy
timeFrame: at 120 minutes
measure: functional capillary density acquired by sublingual microscopy
timeFrame: at 120 minutes
measure: De Backer score acquired by sublingual microscopy
timeFrame: at 120 minutes
measure: heterogeneity of the mean flow index acquired by sublingual microscopy
timeFrame: at 120 minutes
measure: Heart rate
timeFrame: at 120 minutes
measure: systolic arterial pressure
timeFrame: at 120 minutes
measure: diastolic arterial pressure
timeFrame: at 120 minutes
measure: cardiac output measured by transthoracic echocardiography
timeFrame: at 120 minutes
measure: systemic vascular resistance
timeFrame: at 120 minutes
measure: arterial elastance.
timeFrame: at 120 minutes
measure: Ejection fraction of the left ventricle (FEVG)
timeFrame: at 120 minutes
measure: telesystolic volumes of the right ventricle
timeFrame: at 120 minutes
measure: telesystolic volumes of the left ventricle
timeFrame: at 120 minutes
measure: telediastolic volumes of the right ventricle
timeFrame: at 120 minutes
measure: telediastolic volumes of the left ventricle
timeFrame: at 120 minutes
measure: right ventricle contractility (measured with TAPSE and tricuspid S-wave)
timeFrame: at 120 minutes
measure: intracardiac filling pressure profiles (E/a, E/Vp, E/e')
timeFrame: at 120 minutes
measure: oxygen consumption (V02)
timeFrame: at 120 minutes
measure: oxygen delivery (DO2),
timeFrame: at 120 minutes
measure: carbon dioxide production (VCO2)
timeFrame: at 120 minutes
measure: arterial lactate
timeFrame: at 120 minutes
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
Study officials:
affiliation: Hospices Civils de Lyon
name: Matthias Jacquet-Lagrèze
role: PRINCIPAL_INVESTIGATOR
References: