Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery

NCT06802432 | Completed Early Phase 1

• 1 other identifier: FMASU MS 716/2021
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Arrythmia; Anesthesia; Cardiac Surgery; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• overall occurrence of postoperative AF

  during the first 72 hours after cardiac surgery

Secondary Outcomes (2)

• length of the hospital stay

  From the day of the surgery until the date of discharge from the hospital, up to 30 days.

• length of the ICU stay

  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.

Study Arms (2)

Methylprednisolone (MP) group

ACTIVE COMPARATOR

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

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

Control group

NO INTERVENTION

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

Interventions

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)

Methylprednisolone (MP) group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Eman Elshaer, lecturer

  faculty of medicine, ain shams university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 31, 2025
• Study Start: January 1, 2022
• Primary Completion: July 5, 2022
• Study Completion: September 1, 2022
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)