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OpenTrials
Completed

NCT Number: NCT03646773

Microvascular Effects of Intravenous Esmolol During Postoperative Atrial Fibrillation

Background: Postoperative atrial fibrillation (POAF) is commonplace after cardiothoracic surgery. A rate control strategy by using short-acting beta blockers is recommended as a first-line therapy in patients without hemodynamic instability. Microcirculatory effects of POAF and esmolol have not been yet investigated. The investigators made the hypothesis that POAF without hemodynamic instability would induce microvascular dysfunction which could be reversed by intravenous esmolol.

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Key information

Conditions

Postoperative Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • conventional cardiac surgery
  • thoracic surgery

Exclusion criteria

  • Postoperative atrial fibrillation leading to hemodynamic instability

Treatment and study plan

Primary outcomes

  1. effects of POAF without hemodynamic instability on near infrared spectroscopy (NIRS) parameters in combination with a vascular occlusion test

    Time frame: Day 7

    NIRS parameters were restoration speed and desaturation speed. Desaturation speed and resaturation speed of the study were assessed during POAF without esmolol and after a stabilization period of 45 min between each dose of esmolol. An automated pneumatic cuff inflator was positioned at the upper extremity of the ipsilateral upper limb. After completion of a baseline set of measurements for each patient, a rapid arterial occlusion of the upper limb was provoked by inflation of the pneumatic cuff at 50 mmHg above the systolic arterial pressure, up to the StO2 value decreases to 40% or for a maximal period of 10 minutes. The arterial cuff was then rapidly deflated to initiate reperfusion.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Microvascular Effects of Intravenous Esmolol in Patients With Normal Cardiac Function Undergoing Postoperative Atrial Fibrillation: a Prospective Pilot Study in Cardiothoracic Surgery

Acronym: FANI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 24, 2018
Registry last updated
Aug 24, 2018

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.

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