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Landiolol in Postoperative Atrial Fibrillation (MMELPOAF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Landiolol
Placebo
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring landiolol, microcirculation, cardiac surgery, atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital Louis Pradel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Landiolol group

Placebo group

Arm Description

Landiolol perfusion in incremental doses (range 0.5 to 10 µg/kg/min) over 2 hours

Placebo perfusion in incremental doses (range 0.03 to 0.6 mL/kg/h) over 2 hours

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2018
Last Updated
December 18, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03779178
Brief Title
Landiolol in Postoperative Atrial Fibrillation
Acronym
MMELPOAF
Official Title
Microcirculatory and Macrocirculatory Effects of Landiolol in Prevention of Postoperative Atrial Fibrillation: a Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
December 4, 2019 (Actual)
Study Completion Date
December 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
landiolol, microcirculation, cardiac surgery, atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Landiolol group
Arm Type
Experimental
Arm Description
Landiolol perfusion in incremental doses (range 0.5 to 10 µg/kg/min) over 2 hours
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo perfusion in incremental doses (range 0.03 to 0.6 mL/kg/h) over 2 hours
Intervention Type
Drug
Intervention Name(s)
Landiolol
Intervention Description
Landiolol perfusion over 120 minutes in incremental doses : 0.5, 1, 2, 5 and 10 µg/kg/min. Doses are modified every 20 minutes
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Description
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.
Time Frame
at 20 minutes
Title
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Description
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.
Time Frame
at 40 minutes
Title
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Description
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.
Time Frame
at 60 minutes
Title
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Description
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.
Time Frame
at 80 minutes
Title
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Description
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.
Time Frame
at 100 minutes
Title
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Description
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.
Time Frame
at 120 minutes
Secondary Outcome Measure Information:
Title
Microcirculatory mean flow index (MIF) acquired by sublingual microscopy
Time Frame
at 120 minutes
Title
proportion of perfused vessels acquired by sublingual microscopy
Time Frame
at 120 minutes
Title
functional capillary density acquired by sublingual microscopy
Time Frame
at 120 minutes
Title
De Backer score acquired by sublingual microscopy
Time Frame
at 120 minutes
Title
heterogeneity of the mean flow index acquired by sublingual microscopy
Time Frame
at 120 minutes
Title
Heart rate
Description
hemodynamic parameters
Time Frame
at 120 minutes
Title
systolic arterial pressure
Description
hemodynamic parameters
Time Frame
at 120 minutes
Title
diastolic arterial pressure
Description
hemodynamic parameters
Time Frame
at 120 minutes
Title
cardiac output measured by transthoracic echocardiography
Description
hemodynamic parameters
Time Frame
at 120 minutes
Title
systemic vascular resistance
Description
hemodynamic parameters
Time Frame
at 120 minutes
Title
arterial elastance.
Description
hemodynamic parameters
Time Frame
at 120 minutes
Title
Ejection fraction of the left ventricle (FEVG)
Description
echocardiographic parameters
Time Frame
at 120 minutes
Title
telesystolic volumes of the right ventricle
Description
echocardiographic parameters
Time Frame
at 120 minutes
Title
telesystolic volumes of the left ventricle
Description
echocardiographic parameters
Time Frame
at 120 minutes
Title
telediastolic volumes of the right ventricle
Description
echocardiographic parameters
Time Frame
at 120 minutes
Title
telediastolic volumes of the left ventricle
Description
echocardiographic parameters
Time Frame
at 120 minutes
Title
right ventricle contractility (measured with TAPSE and tricuspid S-wave)
Description
echocardiographic parameters
Time Frame
at 120 minutes
Title
intracardiac filling pressure profiles (E/a, E/Vp, E/e')
Description
echocardiographic parameters
Time Frame
at 120 minutes
Title
oxygen consumption (V02)
Description
tissular perfusion parameters
Time Frame
at 120 minutes
Title
oxygen delivery (DO2),
Description
tissular perfusion parameters
Time Frame
at 120 minutes
Title
carbon dioxide production (VCO2)
Description
tissular perfusion parameters
Time Frame
at 120 minutes
Title
arterial lactate
Description
tissular perfusion parameters
Time Frame
at 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Jacquet-Lagrèze
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Louis Pradel
City
Bron
Country
France

12. IPD Sharing Statement

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Landiolol in Postoperative Atrial Fibrillation

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