CompletedPhase 3

Landiolol in Postoperative Atrial Fibrillation

France58 participantsStarted 2019-01-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: at 20 minutes

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

Timeframe: at 40 minutes

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

Timeframe: at 60 minutes

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

Timeframe: at 80 minutes

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

Timeframe: at 100 minutes

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

Timeframe: at 120 minutes

Trial details

NCT IDNCT03779178

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-04

View on ClinicalTrials.gov More Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: at 20 minutes

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

Timeframe: at 40 minutes

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

Timeframe: at 60 minutes

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

Timeframe: at 80 minutes

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

Timeframe: at 100 minutes

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

Timeframe: at 120 minutes