Dexmedetomidine Reduces Atrial Fibrillation in Mechanically Ventilated Patients With COVID-19 Pneumonia

December 22, 2021 updated by: Amr Arafa Elbadry, Tanta University

Dexmedetomidine Sedation Reduces Atrial Fibrillation in Mechanically Ventilated Patients With COVID-19 Pneumonia: a Randomized Controlled Trial

Coronavirus disease 2019 (COVID-19) is a novel, has rapid spread worldwide. Currently, almost 11 million cases have been diagnosed and more than 500,000 infected people have died rather than undiagnosed patients .

Although COVID-19 is mostly characterized by the respiratory tract affection, cardiovascular complications frequently accompany COVID-19 infections increasing morbidity and mortality in such patients .

Arrhythmias are frequently reported in COVID-19 patients, with atrial fibrillation (AF) being the most common form . Although electrical, calcium handling, and structural remodeling plays a key role in AF pathophysiology , the clinical presentation of AF is diverse and the precise mechanisms of AF remain unclear in this large proportion of patients .

In patients with severe pneumonia, acute respiratory distress syndrome (ARDS) and sepsis, the incidence of AF during hospitalization is usually high . For instance, about 23-33% of critically ill patients with sepsis or ARDS have AF recurrences and 10% develop de novo AF.

Dexmedetomidine preserves the natural sleep pattern and induces cooperative sedation in which patients are easily arousable, leading to to less impairment in cognitive function. In addition, it has an opioid sparing effect, and it is associated with a significant decrease in the duration of delirium, ventilatory care along with ICU stay, and therefore it is associated with a significant improvement in outcomes. These mentioned advantages make dexmedetomidine a fundamental sedative in ICU practice .

The use of dexmedetomidine to prevent atrial fibrillation is unclear . However, two retrospective studies also showed that dexmedetomidine sedation might

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All cases will be commenced on invasive mechanical ventilation pressure-controlled ventilation on peak end expiratory pressure (PEEP) ≥ 10 cmH2O, inspiratory pressure (Pi) adjusted to keep plateau pressure less than 30 cmH2O, respiratory rate set between 20 and 35 keeping PH more than 7.15 The included cases will be randomized using the closed envelope method into two groups; Group I will include 72 cases sedated on Propofol infusion 50-200 mg/h + Fentanyl infusion 25-250 mcg/h guided by hemodynamics, whereas Group II will include the remaining 72 cases who will be sedated using the same regimen of group I in addition to Dexmedetomidine infusion 0.2 - 1 mcg/kg/h, and also guided by hemodynamics.

The incidence of AF will be monitored and recorded. AF will be defined as a supraventricular arrhythmia characterized by disorganized atrial depolarization without effective atrial contractions. If AF terminates spontaneously, it is defined as paroxysmal. When AF is sustained beyond seven days or is terminated with electrical or pharmacological cardioversion it is defined as persistent. If a conversion in sinus rhythm cannot be achieved, AF is defined as permanent (24). Also, Troponin level every 8 hours and ECG 3 times all over the day of AF episode.

Management of the attacks of rapid AF will be as follow; in hemodynamically unstable patients, synchronized external direct-current cardioversion will be performed with the pads placed anteriorly and posteriorly (over the sternum and between the scapulae) at 100 joules (J). If no response occurs, the current will be applied again at 200 J; if there is still no response, the current will be increased to 300 J, and then to a maximum of 360 J.

If patients cannot be moved, the pads will be applied over the right sternal border and left lateral chest wall .

In hemodynamically stable patients, amiodarone will be given; with a loading dose of 300 mg iv infusion over 30 min, then a maintenance dose 900 mg iv infusion over 24 hours with monitoring of blood pressure. Metoprolol 25-50 mg tablets bd will be added to the medication list provided hemodynamic stability .

The number of AF attacks in each group will be our primary outcome. Secondary outcomes will include number of cases requiring cardioversion and incidence of mortality.

Measurements:

  1. Number of attacks of AF in each group.
  2. Number of DC shocks.
  3. Total dose of amiodarone.
  4. Total dose of metoprolol.
  5. Incidence of mortality in each group.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • ELgharbiaa
      • Tanta, ELgharbiaa, Egypt, 31527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients age ≥18 years
  • confirmed to have COVID-19 pneumonia by nasopharyngeal swab PCR together with chest radiology
  • requiring invasive mechanical ventilation.

Exclusion Criteria:

  • heart rate <50 beats per minute,
  • atrioventricular conduction block of grade II or III,
  • mean arterial pressure (MAP) <55 mmHg (despite appropriate intravenous volume replacement and vasopressor treatment),
  • acute severe neurological disorder,
  • propofol or dexmedetomidine allergy or other contraindications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dexmedetomidine sedation group
72 cases sedated on Propofol infusion 50-200 mg/h + Fentanyl infusion 25-250 mcg/h guided by hemodynamics in addition to Dexmedetomidine infusion 0.2 - 1 mcg/kg/h, and also guided by hemodynamics.
Procedure: Dexmedetomidine sedation
72 cases sedated on Propofol infusion 50-200 mg/h + Fentanyl infusion 25-250 mcg/h guided by hemodynamics in addition to Dexmedetomidine infusion 0.2 - 1 mcg/kg/h, and also guided by hemodynamics.
OTHER: control group
72 cases sedated on Propofol infusion 50-200 mg/h + Fentanyl infusion 25-250 mcg/h guided by hemodynamics
Procedure: Dexmedetomidine sedation
72 cases sedated on Propofol infusion 50-200 mg/h + Fentanyl infusion 25-250 mcg/h guided by hemodynamics in addition to Dexmedetomidine infusion 0.2 - 1 mcg/kg/h, and also guided by hemodynamics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of atrial fibrillation (AF) attacks
Time Frame: one month
The number of atrial fibrillation (AF) attacks in each group will be our primary outcome
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1) Number of DC shocks
Time Frame: one month
Number of DC shocks
one month
2) Total dose of amiodarone
Time Frame: one month
Total dose of amiodarone
one month
3) Total dose of metoprolol
Time Frame: one month
Total dose of metoprolol
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (ACTUAL)

December 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 22, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dexmedetomidine sedation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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