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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucocorticoid group | Experimental |
| |
| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone Injection | Drug | 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). |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | Up to 30 days | |
| Duration of ICU stay | Up to 30 days | |
| Duration of mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhe Luo, MD, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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|
| 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 |
| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |