Glucocorticoids for Post-operative Patients With Acute Type A Aortic Dissection (The GLAD Trial)

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the effects of glucocorticoid(GC) on improving post-operative organ dysfunction in patients with acute type A aortic dissection. Eligible patients will be randomly assigned on a 1:1 ratio to the GC group and the control group. Patients in the GC group will receive intravenous methylprednisolone from post-operative day 1 to post-operative day 3, while those in the control group will follow standard treatments. The primary outcome is the area under the curve of SOFA score from baseline(pre-operative) to post-operative day 3.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Informed consent

• Age above 18 years old (including 18 years old), regardless of gender;

• Confirmed type A aortic dissection with computer tomography and received surgical intervention

• Life expectancy < 3 days after surgery

Exclusion Criteria:

• History of cardiac surgery within the past 3 months or possible iatrogenic aortic dissection

• Bacterial or fungal infection in the past 30 days

• Glucocorticoid or any other anti-inflammatory drug usage in the past 14 days

• Allergic to glucocorticoid

• Pregnant

• Implantation of ICD or permanent pacemaker

• Patients diagnosed with malignant tumor undergoing chemotherapy and immunotherapy.

• Patients with pre-operative severe liver dysfunction (CTP grade C)

• Patients with pre-operative renal insufficiency (patients receiving renal replacement therapy before surgery)

• Poorly controlled serum glucose with insulin or hypoglycemic drugs