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

NCT05171985 | Unknown

• 1 other identifier: Dexmedetomidine sedation
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19 Pneumonia; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• The number of atrial fibrillation (AF) attacks

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

  one month

Secondary Outcomes (3)

• 1) Number of DC shocks

  one month

• 2) Total dose of amiodarone

  one month

• 3) Total dose of metoprolol

  one month

Study Arms (2)

Dexmedetomidine sedation group

EXPERIMENTAL

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

control group

OTHER

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

Procedure: Dexmedetomidine sedation

Interventions

Dexmedetomidine sedation PROCEDURE

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.

Dexmedetomidine sedation group; control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ELgharbiaa, 31527, Egypt

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amr Elbadry

CONTACT

01283945351; amrarafa009@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 29, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

EG (1)