Post Operative ArrythmiaEarly Phase 1NCT06802432
Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery
A Early Phase 1 study testing 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU) in people with Post Operative Arrythmia and Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Cardiopulmonary bypass and cardiac surgery are associated with a significant systemic inflammatory response that has been suggested playing a causative role in the development of postoperative atrial fibrillation (POAF). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Operative Arrythmia, Anesthesia, Cardiac Surgery
- What is being tested?
- 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Sep 2022
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elective first time CABG or combined with valvular surgery.
- Use of b-adrenergic blockade.
- Normal sinus rhythm.
Who cannot join
- History of heart block
- History of previous episodes of AF or flutter
- History of peptic ulcer disease
- Permanent pacemaker
- Any documented or suspected supraventricular or ventricular arrhythmias
- Renal insufficiency (serum creatinine >20 mg/dL)
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- Uncontrolled diabetes mellitus
- Systemic bacterial or mycotic infection
- Urgent or emergency surgery
- Patient underwent cardiac surgery without using cardiopulmonary bypass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Corticosteroids on Prophylaxis of New-onset Arterial Fibrillation After Cardiac Surgery
Cardiopulmonary bypass and cardiac surgery are associated with a significant systemic inflammatory response that has been suggested playing a causative role in the development of postoperative atrial fibrillation (POAF). The goal of this study is to determine the efficacy of corticosteroids prophylaxis in preventing POAF, or length of intensive care unit (ICU) or hospital stay.
Read the detailed description
Most cardiac operations are performed under cardiopulmonary bypass, however, it is well known that cardiopulmonary bypass often causes systemic inflammatory response characterized by leukocyte and high levels of C-reactive protein (CRP) complexes, as well high levels of inflammatory mediators that may contribute to postoperative complications including atrial fibrillation (AF), prolonged duration of intensive care unit (ICU) and hospital stay.
Postoperative atrial fibrillation has (POAF) been reported in 20% to 50% of patients following coronary artery bypass grafting (CABG) and is even higher after combined CABG and valve surgery.
It may increase stroke rates, trigger hemodynamic instability with heart failure and increase risk of thromboembolic complications.
The relationship between inflammation and atrial fibrillation after cardiac surgery is further strengthened by studies that showed that corticosteroid (CS) prophylaxis can reduce the occurrence of atrial fibrillation after cardiac surgery.
Corticosteroids (CS) can reduce the risk of atrial fibrillation after cardiac surgery in adults and reduce length of intensive care unit (ICU) and hospital stay.
It is a low-cost drug that can effectively inhibit inflammation, limit systemic capillary leakage syndrome and reduce organ damage, thus providing a theoretical basis for its clinical application.
However, the potential risks of CS remain controversial and inconclusive in terms of several side effects of CS such as hyperglycemia, gastrointestinal disturbances, and postoperative infections.
- Conditions
- Post Operative Arrythmia, Anesthesia, Cardiac Surgery, Corticosteroids
- Being tested
- 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)Drug
1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone (MP) group | Active comparator | 42 patients, given 1 g of methylprednisolone post cardiopulmonary bypass immediately postoperative Receives: Drug: 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU) |
| Control group | No intervention | 42 patients, underwent a standard cardiopulmonary bypass without any additional medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall occurrence of postoperative AF
Measured: during the first 72 hours after cardiac surgery
Secondary outcomes (2)
length of the hospital stay
From the day of the surgery until the date of discharge from the hospital, which varies depending on the patient's clinical condition.
Measured: From the day of the surgery until the date of discharge from the hospital, up to 30 days.
length of the ICU stay
From the day of the surgery ( postoperative ICU admission) until the time of transfer from the ICU to the surgical ward , which varies depending on the patient's clinical condition.
Measured: from the day of the surgery ( postoperative ICU admission) until the time of transfer from the ICU to the surgical ward , up to 25 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jan 2022
- Primary completion5 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative ArrythmiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman mohamed hesham elshaer, Ain Shams University
- Investigators
- Eman Elshaer, lecturer, Principal investigator, faculty of medicine, ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802432
- Sponsor's protocol ID
- FMASU MS 716/2021
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Corticosteroids on Prophylaxis of New-onset Arterial Fibrillation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06802432
- Acronym / sponsor ID
- FMASU MS 716/2021
- Conditions
- Post Operative Arrythmia, Anesthesia, Cardiac Surgery, Corticosteroids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 31 Jan 2025 (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.
Cardiopulmonary bypass and cardiac surgery are associated with a significant systemic inflammatory response that has been suggested playing a causative role in the development of postoperative atrial fibrillation (POAF). The goal of this study is to determine the efficacy of corticosteroids prophylaxis in preventing POAF, or length of intensive care unit (ICU) or hospital stay.
Detailed description
Most cardiac operations are performed under cardiopulmonary bypass, however, it is well known that cardiopulmonary bypass often causes systemic inflammatory response characterized by leukocyte and high levels of C-reactive protein (CRP) complexes, as well high levels of inflammatory mediators that may contribute to postoperative complications including atrial fibrillation (AF), prolonged duration of intensive care unit (ICU) and hospital stay.
Postoperative atrial fibrillation has (POAF) been reported in 20% to 50% of patients following coronary artery bypass grafting (CABG) and is even higher after combined CABG and valve surgery.
It may increase stroke rates, trigger hemodynamic instability with heart failure and increase risk of thromboembolic complications.
The relationship between inflammation and atrial fibrillation after cardiac surgery is further strengthened by studies that showed that corticosteroid (CS) prophylaxis can reduce the occurrence of atrial fibrillation after cardiac surgery.
Corticosteroids (CS) can reduce the risk of atrial fibrillation after cardiac surgery in adults and reduce length of intensive care unit (ICU) and hospital stay.
It is a low-cost drug that can effectively inhibit inflammation, limit systemic capillary leakage syndrome and reduce organ damage, thus providing a theoretical basis for its clinical application.
However, the potential risks of CS remain controversial and inconclusive in terms of several side effects of CS such as hyperglycemia, gastrointestinal disturbances, and postoperative infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone (MP) group | Active comparator | Drug: 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)42 patients, given 1 g of methylprednisolone post cardiopulmonary bypass immediately postoperative |
| Control group | No intervention | –42 patients, underwent a standard cardiopulmonary bypass without any additional medications |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Elective first time CABG or combined with valvular surgery.
- Use of b-adrenergic blockade.
- Normal sinus rhythm.
Key exclusion criteria (10 listed)
- History of heart block
- History of previous episodes of AF or flutter
- History of peptic ulcer disease
- Permanent pacemaker
- Any documented or suspected supraventricular or ventricular arrhythmias
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 |
|---|---|---|
| 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU) | Drug | Methylprednisolone (MP) group |
Primary outcome
overall occurrence of postoperative AF
Time frame: during the first 72 hours after cardiac surgery
2 secondary outcomes
length of the hospital stay
Time frame: From the day of the surgery until the date of discharge from the hospital, up to 30 days.
length of the ICU stay
Time frame: from the day of the surgery ( postoperative ICU admission) until the time of transfer from the ICU to the surgical ward , up to 25 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Eman Elshaer, lecturer principal investigator
faculty of medicine, ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU) in people with Post Operative Arrythmia and Anesthesia, run by Ain Shams 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 10 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: finished, as of the sponsor's last update on 31 Jan 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall occurrence of postoperative AF (time frame: during the first 72 hours after cardiac surgery). 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 31 Jan 2025.