Landiolol in Postoperative Atrial Fibrillation

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Landiolol; Drug: Placebo

• Registration Number: NCT03779178
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-19
• Study Start: 2019-01-17
• Status Verified: 2019-12
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-04
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Landiolol group	Landiolol	Landiolol perfusion in incremental doses (range 0.5 to 10 µg/kg/min) over 2 hours
Placebo group	Placebo	Placebo perfusion in incremental doses (range 0.03 to 0.6 mL/kg/h) over 2 hours

Primary Outcome Measures

Name	Time	Method
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)	at 120 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 Outcome Measures

Name	Time	Method
cardiac output measured by transthoracic echocardiography	at 120 minutes	hemodynamic parameters
Microcirculatory mean flow index (MIF) acquired by sublingual microscopy	at 120 minutes
proportion of perfused vessels acquired by sublingual microscopy	at 120 minutes
heterogeneity of the mean flow index acquired by sublingual microscopy	at 120 minutes
systolic arterial pressure	at 120 minutes	hemodynamic parameters
diastolic arterial pressure	at 120 minutes	hemodynamic parameters
systemic vascular resistance	at 120 minutes	hemodynamic parameters
carbon dioxide production (VCO2)	at 120 minutes	tissular perfusion parameters
arterial lactate	at 120 minutes	tissular perfusion parameters
functional capillary density acquired by sublingual microscopy	at 120 minutes
Heart rate	at 120 minutes	hemodynamic parameters
Ejection fraction of the left ventricle (FEVG)	at 120 minutes	echocardiographic parameters
telediastolic volumes of the left ventricle	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
De Backer score acquired by sublingual microscopy	at 120 minutes
telesystolic volumes of the left ventricle	at 120 minutes	echocardiographic parameters
telediastolic volumes of the right ventricle	at 120 minutes	echocardiographic parameters
oxygen delivery (DO2),	at 120 minutes	tissular perfusion parameters
telesystolic volumes of the right ventricle	at 120 minutes	echocardiographic parameters
arterial elastance.	at 120 minutes	hemodynamic parameters
right ventricle contractility (measured with TAPSE and tricuspid S-wave)	at 120 minutes	echocardiographic parameters

Trial Locations

Locations (1)

Hôpital Louis Pradel; 🇫🇷 Bron, France