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Completed

NCT Number: NCT06802432

Corticosteroids Prevent the Atrial 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Medicine, Ain Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. overall occurrence of postoperative AF

    Time frame: during the first 72 hours after cardiac surgery

Secondary outcomes

  1. 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.

    From the day of the surgery until the date of discharge from the hospital, which varies depending on the patient's clinical condition.

  2. 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.

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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