Landiolol in Postoperative Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— MMELPOAF  

Official title:

Microcirculatory and Macrocirculatory Effects of Landiolol in Prevention of Postoperative Atrial Fibrillation: a Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779178
• Other study ID #: 69HCL16_0743
• Secondary ID: 2018-000307-17
• Status: Completed
• Phase: Phase 3
• Start date: January 17, 2019
• Est. completion date: December 4, 2019

Study information

• Verified date: December 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Landiolol
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
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.

Locations

Country	Name	City	State
France	Hôpital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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 100 minutes
Primary	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
Secondary	Microcirculatory mean flow index (MIF) acquired by sublingual microscopy		at 120 minutes
Secondary	proportion of perfused vessels acquired by sublingual microscopy		at 120 minutes
Secondary	functional capillary density acquired by sublingual microscopy		at 120 minutes
Secondary	De Backer score acquired by sublingual microscopy		at 120 minutes
Secondary	heterogeneity of the mean flow index acquired by sublingual microscopy		at 120 minutes
Secondary	Heart rate	hemodynamic parameters	at 120 minutes
Secondary	systolic arterial pressure	hemodynamic parameters	at 120 minutes
Secondary	diastolic arterial pressure	hemodynamic parameters	at 120 minutes
Secondary	cardiac output measured by transthoracic echocardiography	hemodynamic parameters	at 120 minutes
Secondary	systemic vascular resistance	hemodynamic parameters	at 120 minutes
Secondary	arterial elastance.	hemodynamic parameters	at 120 minutes
Secondary	Ejection fraction of the left ventricle (FEVG)	echocardiographic parameters	at 120 minutes
Secondary	telesystolic volumes of the right ventricle	echocardiographic parameters	at 120 minutes
Secondary	telesystolic volumes of the left ventricle	echocardiographic parameters	at 120 minutes
Secondary	telediastolic volumes of the right ventricle	echocardiographic parameters	at 120 minutes
Secondary	telediastolic volumes of the left ventricle	echocardiographic parameters	at 120 minutes
Secondary	right ventricle contractility (measured with TAPSE and tricuspid S-wave)	echocardiographic parameters	at 120 minutes
Secondary	intracardiac filling pressure profiles (E/a, E/Vp, E/e')	echocardiographic parameters	at 120 minutes
Secondary	oxygen consumption (V02)	tissular perfusion parameters	at 120 minutes
Secondary	oxygen delivery (DO2),	tissular perfusion parameters	at 120 minutes
Secondary	carbon dioxide production (VCO2)	tissular perfusion parameters	at 120 minutes
Secondary	arterial lactate	tissular perfusion parameters	at 120 minutes