Methylprednisolone for acute type A aortic dissection patients undergoing total arch replacement: Design and rationale of the Medal trial

• Published in: The American heart journal Vol. 279; pp. 20 - 26
• Main Authors: Yan, Shujie, Jiang, Fuqing, Sun, Yanhua, Wang, Yang, Ye, Jianxi, Li, Jianchao, Yang, Hui, Wang, Shifu, Song, Yi, Zhou, Chengbin, Ji, Bingyang
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.01.2025; Elsevier Limited
• Subjects: Acute Disease; Adult; Anesthesia; Anti-inflammatory agents; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - therapeutic use; Aorta; Aorta, Thoracic - surgery; Aortic Aneurysm, Thoracic - surgery; Aortic arch; Aortic dissection; Aortic Dissection - surgery; Blood Vessel Prosthesis Implantation - methods; Cardiopulmonary Bypass - methods; Clinical outcomes; Clinical trials; Creatinine; Data collection; Dissection; Double-Blind Method; Emergency response; Female; Hospitals; Humans; Inflammation; Inflammatory response; Intubation; Ischemia; Kidneys; Male; Medical personnel; Methylprednisolone; Methylprednisolone - administration & dosage; Methylprednisolone - therapeutic use; Middle Aged; Morbidity; Mortality; Ostomy; Patients; Placebos; Postoperative Complications - epidemiology; Postoperative Complications - prevention & control; Prospective Studies; Spinal cord; Surgeons; Surgery; Tracheostomy; Tracheotomy; Veins & arteries; Wound healing; China
• ISSN: 0002-8703; 1097-6744; 1097-6744
• DOI: 10.1016/j.ahj.2024.10.003

The mortality and morbidity of emergency total aortic arch replacement (TAAR) for acute type A aortic dissection (ATAAD) is high, which is partly due to the excessively activated systemic inflammatory response. Methylprednisolone, an anti-inflammatory agent, might suppress the systemic inflammatory response and lead to improved outcomes. However, the protective effects of methylprednisolone on TAAR for ATAAD were not clarified. The usage and dosage varied in different centers across the world. The Medal trial is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate whether 500 mg methylprednisolone IV before cardiopulmonary bypass could reduce the incidence of postoperative major organ injury, compared to placebo. Adult patients with the diagnosis with ATAAD, awaiting emergency total aortic arch replacement with hypothermic circulatory arrest and selective cerebral perfusion will be included in the trial. A total of 340 eligible subjects from 9 large cardiovascular centers will be randomized in a 1:1 ratio to receive 500 mg methylprednislone or placebo before cardiopulmonary bypass. The primary outcome is postoperative major adverse outcome [defined as all-cause death or postoperative neurological deficit or KDIGO II -III acute kidney injury or respiratory syndrome (tracheal intubation> 72 hours, tracheostomy or re-intubation) until postoperative day 30 or patient discharge]. The study has received approval from the local Ethics Committees of the 9 participating centers, and enrolled its first subject in June 24, 2022. As of September 5, 2024, 323 subjects have been enrolled. Results of the Medal trial will be published once data collection and analysis have been completed. The Medal trial will determine the effectiveness of 500 mg methylprednisolone on the outcomes of patients with ATAAD undergoing TAAR. URL https://www.chictr.org.cn/searchprojEN.html (Chinese Clinical Trial Registry). Unique identifier: ChiCTR2200059286