Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery

January 29, 2025 updated by: Eman mohamed hesham elshaer, Ain Shams University

Use of Corticosteroids on Prophylaxis of New-onset Arterial 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Medicine, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methylprednisolone (MP) group
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)
1 g of methylprednisolone (divided into 250 mg every 6h started once the patient arrived the pos-toparative ICU)
No Intervention: Control group
42 patients, underwent a standard cardiopulmonary bypass without any additional medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall occurrence of postoperative AF
Time Frame: during the first 72 hours after cardiac surgery
during the first 72 hours after cardiac surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the day of the surgery until the date of discharge from the hospital, up to 30 days.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Eman Elshaer, lecturer, Faculty of Medicine, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

July 5, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS 716/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe