Clinical trial NCT06802432: Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery
Official title: Use of Corticosteroids on Prophylaxis of New-onset Arterial Fibrillation After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Post Operative Arrythmia
Anesthesia
Cardiac Surgery
Corticosteroids
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* Elective first time CABG or combined with valvular surgery.
* Use of b-adrenergic blockade.
* Normal sinus rhythm.

Exclusion Criteria:

* 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)
* Uncontrolled diabetes mellitus
* Systemic bacterial or mycotic infection
* Urgent or emergency surgery
* Patient underwent cardiac surgery without using cardiopulmonary bypass

Primary outcomes:
measure: overall occurrence of postoperative AF
timeFrame: during the first 72 hours after cardiac surgery
Secondary outcomes:
measure: length of the hospital stay
timeFrame: From the day of the surgery until the date of discharge from the hospital, up to 30 days.
measure: length of the ICU stay
timeFrame: 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.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
Study officials:
affiliation: faculty of medicine, ain shams university
name: Eman Elshaer, lecturer
role: PRINCIPAL_INVESTIGATOR
References: