Dexmedetomidine Reduces Atrial Fibrillation in Mechanically Ventilated Patients With COVID-19 Pneumonia
NCT ID: NCT05171985
Last Updated: 2021-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
144 participants
INTERVENTIONAL
2022-01-31
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
control group
72 cases sedated on Propofol infusion 50-200 mg/h + Fentanyl infusion 25-250 mcg/h guided by hemodynamics
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* confirmed to have COVID-19 pneumonia by nasopharyngeal swab PCR together with chest radiology
* requiring invasive mechanical ventilation.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tanta University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Amr Arafa Elbadry
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tanta University Hospitals
Tanta, ELgharbiaa, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Amr Elbadry
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Dexmedetomidine sedation
Identifier Type: -
Identifier Source: org_study_id