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

Primary Purpose

COVID-19 Pneumonia, Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine sedation
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tanta University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dexmedetomidine sedation group

control group

Arm Description

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.

72 cases sedated on Propofol infusion 50-200 mg/h + Fentanyl infusion 25-250 mcg/h guided by hemodynamics

Outcomes

Primary Outcome Measures

The number of atrial fibrillation (AF) attacks
The number of atrial fibrillation (AF) attacks in each group will be our primary outcome

Secondary Outcome Measures

1) Number of DC shocks
Number of DC shocks
2) Total dose of amiodarone
Total dose of amiodarone
3) Total dose of metoprolol
Total dose of metoprolol

Full Information

First Posted
December 20, 2021
Last Updated
December 22, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05171985
Brief Title
Dexmedetomidine Reduces Atrial Fibrillation in Mechanically Ventilated Patients With COVID-19 Pneumonia
Official Title
Dexmedetomidine Sedation Reduces Atrial Fibrillation in Mechanically Ventilated Patients With COVID-19 Pneumonia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

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

5. Study Description

Brief Summary
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
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: Number of attacks of AF in each group. Number of DC shocks. Total dose of amiodarone. Total dose of metoprolol. Incidence of mortality in each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine sedation group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Other
Arm Description
72 cases sedated on Propofol infusion 50-200 mg/h + Fentanyl infusion 25-250 mcg/h guided by hemodynamics
Intervention Type
Procedure
Intervention Name(s)
Dexmedetomidine sedation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of atrial fibrillation (AF) attacks
Description
The number of atrial fibrillation (AF) attacks in each group will be our primary outcome
Time Frame
one month
Secondary Outcome Measure Information:
Title
1) Number of DC shocks
Description
Number of DC shocks
Time Frame
one month
Title
2) Total dose of amiodarone
Description
Total dose of amiodarone
Time Frame
one month
Title
3) Total dose of metoprolol
Description
Total dose of metoprolol
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Elbadry
Phone
01283945351
Email
amrarafa009@gmail.com
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
ELgharbiaa
ZIP/Postal Code
31527
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr Elbadry
Phone
01283945351
Email
amrarafa009@gmail.com

12. IPD Sharing Statement

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

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