Skip to main content
OpenTrials
Completed

NCT Number: NCT03779178

Landiolol in Postoperative Atrial Fibrillation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Louis Pradel

Bron, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

Primary outcomes

  1. Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

    Time frame: 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.

  2. Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

    Time frame: at 40 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.

  3. Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

    Time frame: at 60 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.

  4. Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

    Time frame: at 80 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.

  5. Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

    Time frame: at 100 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.

  6. Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

    Time frame: 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 outcomes

  1. Microcirculatory mean flow index (MIF) acquired by sublingual microscopy

    Time frame: at 120 minutes

  2. proportion of perfused vessels acquired by sublingual microscopy

    Time frame: at 120 minutes

  3. functional capillary density acquired by sublingual microscopy

    Time frame: at 120 minutes

  4. De Backer score acquired by sublingual microscopy

    Time frame: at 120 minutes

  5. heterogeneity of the mean flow index acquired by sublingual microscopy

    Time frame: at 120 minutes

  6. Heart rate

    Time frame: at 120 minutes

    hemodynamic parameters

  7. systolic arterial pressure

    Time frame: at 120 minutes

    hemodynamic parameters

  8. diastolic arterial pressure

    Time frame: at 120 minutes

    hemodynamic parameters

  9. cardiac output measured by transthoracic echocardiography

    Time frame: at 120 minutes

    hemodynamic parameters

  10. systemic vascular resistance

    Time frame: at 120 minutes

    hemodynamic parameters

  11. arterial elastance.

    Time frame: at 120 minutes

    hemodynamic parameters

  12. Ejection fraction of the left ventricle (FEVG)

    Time frame: at 120 minutes

    echocardiographic parameters

  13. telesystolic volumes of the right ventricle

    Time frame: at 120 minutes

    echocardiographic parameters

  14. telesystolic volumes of the left ventricle

    Time frame: at 120 minutes

    echocardiographic parameters

  15. telediastolic volumes of the right ventricle

    Time frame: at 120 minutes

    echocardiographic parameters

  16. telediastolic volumes of the left ventricle

    Time frame: at 120 minutes

    echocardiographic parameters

  17. right ventricle contractility (measured with TAPSE and tricuspid S-wave)

    Time frame: at 120 minutes

    echocardiographic parameters

  18. intracardiac filling pressure profiles (E/a, E/Vp, E/e')

    Time frame: at 120 minutes

    echocardiographic parameters

  19. oxygen consumption (V02)

    Time frame: at 120 minutes

    tissular perfusion parameters

  20. oxygen delivery (DO2),

    Time frame: at 120 minutes

    tissular perfusion parameters

  21. carbon dioxide production (VCO2)

    Time frame: at 120 minutes

    tissular perfusion parameters

  22. arterial lactate

    Time frame: at 120 minutes

    tissular perfusion parameters

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: MMELPOAF

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.