Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery

Ain Shams University

Status and phase: Completed; Early Phase 1

Conditions: Cardiac Surgery; Corticosteroids; Post Operative Arrythmia; Anesthesia

Treatments: Drug: 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)

Study type: Interventional

Funder types: Other

Identifiers

NCT06802432

FMASU MS 716/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Methylprednisolone (MP) group

Active Comparator group

Description:

42 patients, given 1 g of methylprednisolone post cardiopulmonary bypass immediately postoperative

Treatment:

Drug: 1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)

Control group

No Intervention group

Description:

42 patients, underwent a standard cardiopulmonary bypass without any additional medications