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

Aortic Dissection Clinical Trial

Official title:

Assessment of the Efficacy of Glucocorticoids in Improving Post-operative Organ Dysfunction in Patients With Acute Type A Aortic Dissection(GLAD): a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05329740
• Other study ID #: B2022-030R2
• Status: Completed
• Phase: Phase 4
• Start date: February 7, 2022
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Dissection
• Glucocorticoid
• Methylprednisolone
• Organ Dysfunction

Intervention

Drug:
• Methylprednisolone Injection
All eligible patients randomised to the glucocorticoid group will receive intravenous Methylprednisolone for 3 days after surgery. The dosage is 2mg/kg/d on post-operative day 1, 1mg/kg/d on post-operative day 2, and 0.5mg/kg/d on post-operative day 3. The daily dosage will be administered with two injections (12h interval).

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of variation of SOFA score on post-operative day 4 compared to baseline		Within 4 days on admission to CSICU
Secondary	In-hospital mortality		Up to 30 days
Secondary	Duration of ICU stay		Up to 30 days
Secondary	Duration of mechanical ventilation		Up to 30 days
Secondary	Duration of hospital stay		Up to 30 days
Secondary	The proportion of patients receiving RRT	Use of Renal Replacement Therapy(RRT)	Up to 30 days
Secondary	The duration of RRT will be compared between two groups.	Use of Renal Replacement Therapy(RRT)	Up to 30 days
Secondary	Incidence of Tracheostomy		Up to 30 days
Secondary	Incidence of Post-operative infection		Up to 30 days
Secondary	Changes in Inflammation markers	Inflammation markers include IL-1, IL2R, IL-6 and TNFa	Within 3 days on admission to CSICU
Secondary	Rate of Composite outcome	In-hospital mortality or Duration of ICU stay longer than 30 days or The need for tracheostomy	Up to 30 days