Postoperative Atrial Fibrillation Clinical Trial
— FANIOfficial title:
Microvascular Effects of Intravenous Esmolol in Patients With Normal Cardiac Function Undergoing Postoperative Atrial Fibrillation: a Prospective Pilot Study in Cardiothoracic Surgery
NCT number | NCT03646773 |
Other study ID # | 69HCL16_0743_1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2015 |
Est. completion date | November 2016 |
Verified date | August 2018 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | November 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - conventional cardiac surgery - thoracic surgery Exclusion Criteria: - Postoperative atrial fibrillation leading to hemodynamic instability |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | effects of POAF without hemodynamic instability on near infrared spectroscopy (NIRS) parameters in combination with a vascular occlusion test | 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. | Day 7 |
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