Methylprednisolone, Glucocorticoid, Aortic Dissection, Organ Dysfunction
Conditions
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.
Interventions
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).
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 30 days | Use of Renal Replacement Therapy(RRT) |
| In-hospital mortality | Up to 30 days | — |
| 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 |
| 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 |
| The duration of RRT will be compared between two groups. | Up to 30 days | Use of Renal Replacement Therapy(RRT) |
Countries
China
Outcome results
None listed