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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Methylprednisolone, Glucocorticoid, Aortic Dissection, Organ Dysfunction

Intervention / Treatment
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* Drug: Methylprednisolone Injection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucocorticoid group<br> | Drug: Methylprednisolone Injection<br>* 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).<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |