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

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

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.

Study Overview

• Status: Completed
• Conditions: Methylprednisolone; Aortic Dissection; Organ Dysfunction; Glucocorticoid
• Intervention / Treatment: Drug: Methylprednisolone Injection

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Glucocorticoid group	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amplitude of variation of SOFA score on post-operative day 4 compared to baseline	Within 4 days on admission to CSICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality		Up to 30 days
Duration of ICU stay		Up to 30 days
Duration of mechanical ventilation		Up to 30 days
Duration of hospital stay		Up to 30 days
The proportion of patients receiving RRT	Use of Renal Replacement Therapy(RRT)	Up to 30 days
The duration of RRT will be compared between two groups.	Use of Renal Replacement Therapy(RRT)	Up to 30 days
Incidence of Tracheostomy		Up to 30 days
Incidence of Post-operative infection		Up to 30 days
Changes in Inflammation markers	Inflammation markers include IL-1, IL2R, IL-6 and TNFa	Within 3 days on admission to CSICU
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Zhe Luo, MD, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: B2022-030R2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No