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

Phase 4

Completed

• Conditions: Methylprednisolone; Glucocorticoid; Aortic Dissection; Organ Dysfunction
• Interventions: Drug: Methylprednisolone Injection

• Registration Number: NCT05329740
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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(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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-07
• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-15
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucocorticoid group	Methylprednisolone Injection	-

Primary Outcome Measures

Name	Time	Method
Amplitude of variation of SOFA score on post-operative day 4 compared to baseline	Within 4 days on admission to CSICU

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	Up to 30 days
The proportion of patients receiving RRT	Up to 30 days	Use of Renal Replacement Therapy(RRT)
Incidence of Tracheostomy	Up to 30 days
Incidence of Post-operative infection	Up to 30 days
Changes in Inflammation markers	Within 3 days on admission to CSICU	Inflammation markers include IL-1, IL2R, IL-6 and TNFa
Duration of ICU stay	Up to 30 days
In-hospital mortality	Up to 30 days
The duration of RRT will be compared between two groups.	Up to 30 days	Use of Renal Replacement Therapy(RRT)
Duration of hospital stay	Up to 30 days
Rate of Composite outcome	Up to 30 days	In-hospital mortality or Duration of ICU stay longer than 30 days or The need for tracheostomy

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China