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Intrapericardial Methylprednisolone for the Prevention of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial

Intrapericardial Methylprednisolone for the Prevention of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113480
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-11-28
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative atrial fibrillation

Interventions

Experimental Group:1.catheter for local administration of drugs to the heart is placed in front of the chest after heart surgery. 2.Before closing the chest and two days after the operation, administe
Control group:1.A catheter for local administration of drugs to the heart is placed in front of the chest after heart surgery. 2. Administer the same volume of normal saline to the chest and two days

Sponsors

Beijing Anzhen Hospital, affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Elective off-pump coronary artery bypass grafting 2. Age >=18 years old; 3. Voluntarily participate in the research.

Exclusion criteria

Exclusion criteria: 1.Before the operation, there were atrial fibrillation, atrial flutter, sick sinoatrial node syndrome, and high-grade atrioventricular block. 2. Use systemic glucocorticoids (excluding inhalation/topical) or antiarrhythmic drugs (excluding beta-blockers) within 30 days before the operation; 3. Previously received a pacemaker/automated internal defibrillator; 4. Poor control of hyperthyroidism; 5. After the operation began, the doctor decided to perform other heart surgeries simultaneously, including but not limited to valve surgeries; 6. Two or more heart surgeries; 7. Received or planned to receive systemic glucocorticoid treatment after the operation; 8. Allergic or intolerant to glucocorticoids; 9. Abnormal liver and kidney functions (liver enzymes elevated to three times the normal value); 10. Before coronary artery bypass grafting, mechanical or drug treatment is required to support hemodynamics. 11. There has been a history of bacterial or fungal infection (or myocardial infection) within the past 30 days; 12. Participate in other clinical trials that may interfere with the results of this study 13. Inability to conduct reliable heart rhythm monitoring (such as refusing to wear monitoring devices) 14. The patient is pregnant and breastfeeding 15. Poor control of diabetes or severe immunosuppressive state

Design outcomes

Primary

MeasureTime frame
Postoperative atrial fibrillation;

Secondary

MeasureTime frame
Frequency of AF episodes;Cumulative duration of atrial fibrillation;Atrial fibrillation burden;Incidence of any postoperative arrhythmia or requirement for anti-arrhythmic therapy;Levels of inflammatory markers in pericardial drainage fluid;Postoperative systemic inflammatory levels;Postoperative delirium;Postoperative cognitive function;Incidence of postoperative stroke;Incidence of postoperative Myocardial Infarction ;Re-exploration for bleeding;Postoperative use of Intra-Aortic Balloon Pump (IABP);Requirement for postoperative blood transfusion;Postoperative cardiac tamponade;Postoperative Gastrointestinal (GI) bleeding;Postoperative infection;Blood glucose levels in the ICU;Postoperative insulin requirement;Length of Hospital Stay;Intervention-related costs;Treatment costs of major complications;Health-Related Quality of Life (assessed by SF-36 or EQ-5D);

Countries

China

Contacts

Public ContactXiubin Yang

Beijing Anzhen Hospital, affiliated to Capital Medical University

xiubinyang@hotmail.com+86 139 1168 6867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026