Clinical Trials Directory

Trials / Completed

CompletedNCT06802432

Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery

Use of Corticosteroids on Prophylaxis of New-onset Arterial Fibrillation After Cardiac Surgery

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
84 (actual)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUG1 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)

Timeline

Start date
2022-01-01
Primary completion
2022-07-05
Completion
2022-09-01
First posted
2025-01-31
Last updated
2025-01-31

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06802432. Inclusion in this directory is not an endorsement.