Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery

NCT ID: NCT06802432

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-09-01

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.

Conditions

Post Operative Arrythmia; Anesthesia; Cardiac Surgery; Corticosteroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Methylprednisolone (MP) group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Eman mohamed hesham elshaer

lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman Elshaer, lecturer

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine, ain shams university

Locations

Faculty of Medicine, Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS 716/2021

Identifier Type: -

Identifier Source: org_study_id