COVID-19 PneumoniaNCT05171985
Dexmedetomidine Reduces Atrial Fibrillation in Mechanically Ventilated Patients With COVID-19 Pneumonia
A study testing Dexmedetomidine sedation in people with COVID-19 Pneumonia and Atrial Fibrillation, run by Tanta University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Pneumonia, Atrial Fibrillation
- What is being tested?
- Dexmedetomidine sedation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2022to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age ≥18 years
- confirmed to have COVID-19 pneumonia by nasopharyngeal swab PCR together with chest radiology
- requiring invasive mechanical ventilation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tanta University Hospitals
Tanta, ELgharbiaa, 31527
Amr Elbadry, 01283945351, amrarafa009@gmail.com
About this study
Official title: 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 .
Read more
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
Read the 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.
- Conditions
- COVID-19 Pneumonia, Atrial Fibrillation
- Being tested
- Dexmedetomidine sedation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine sedationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Dexmedetomidine sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of atrial fibrillation (AF) attacks
The number of atrial fibrillation (AF) attacks in each group will be our primary outcome
Measured: one month
Secondary outcomes (3)
1) Number of DC shocks
Number of DC shocks
Measured: one month
2) Total dose of amiodarone
Total dose of amiodarone
Measured: one month
3) Total dose of metoprolol
Total dose of metoprolol
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Arafa Elbadry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171985
- Sponsor's protocol ID
- Dexmedetomidine sedation
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Sedation Reduces Atrial Fibrillation in Mechanically Ventilated Patients With COVID-19 Pneumonia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05171985
- Acronym / sponsor ID
- Dexmedetomidine sedation
- Conditions
- COVID-19 Pneumonia, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine sedation group | Experimental | Procedure: Dexmedetomidine sedation72 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 | Other | Procedure: Dexmedetomidine sedation72 cases sedated on Propofol infusion 50-200 mg/h + Fentanyl infusion 25-250 mcg/h guided by hemodynamics |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age ≥18 years
- confirmed to have COVID-19 pneumonia by nasopharyngeal swab PCR together with chest radiology
- requiring invasive mechanical ventilation.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine sedation72 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 or surgery | Dexmedetomidine sedation group, control group |
Primary outcome
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
3 secondary outcomes
1) Number of DC shocks
Time frame: one month
2) Total dose of amiodarone
Time frame: one month
3) Total dose of metoprolol
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine sedation in people with COVID-19 Pneumonia and Atrial Fibrillation, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Elbadry (01283945351, amrarafa009@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of atrial fibrillation (AF) attacks (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.