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

Fudan University

Status and phase

Completed

Phase 4

Conditions

Glucocorticoid

Methylprednisolone

Aortic Dissection

Organ Dysfunction

Treatments

Drug: Methylprednisolone Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT05329740

B2022-030R2

Details and patient eligibility

About

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(aTAAD). Subjects with confirmed diagnosis of aTAAD undergoing surgical treatment will be enrolled and 1:1 randomly assigned to receive either glucocorticoids or normal treatment. All patients in the glucocorticoids group will be given methylprednisolone intravenously for 3 days after enrollment. The primary endpoint will be the amplitude of variation of Sequential Organ Failure Assessment score on post-operative day 4 compared to baseline.

Enrollment

212 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)