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Microvascular Effects of Intravenous Esmolol During Postoperative Atrial Fibrillation (FANI)

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ClinicalTrials.gov Identifier: NCT03646773
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
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.

Condition or disease
Postoperative Atrial Fibrillation

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microvascular Effects of Intravenous Esmolol in Patients With Normal Cardiac Function Undergoing Postoperative Atrial Fibrillation: a Prospective Pilot Study in Cardiothoracic Surgery
Actual Study Start Date : December 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients scheduled for conventional cardiac or thoracic surgery who experienced in-hospital postoperative atrial fibrillation within the first seven postoperative days
Criteria

Inclusion Criteria:

  • conventional cardiac surgery
  • thoracic surgery

Exclusion Criteria:

  • Postoperative atrial fibrillation leading to hemodynamic instability

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03646773     History of Changes
Other Study ID Numbers: 69HCL16_0743_1
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Esmolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs