Microvascular Effects of Intravenous Esmolol During Postoperative Atrial Fibrillation

NCT03646773 | Completed

• 1 other identifier: 69HCL16_0743_1
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• conventional cardiac surgery
• thoracic surgery

You may not qualify if:

• Postoperative atrial fibrillation leading to hemodynamic instability

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 24, 2018
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 24, 2018

Record last verified: 2018-08