Clinical trial NCT05329740: Glucocorticoids for Post-operative Patients With Acute Type A Aortic Dissection (The GLAD 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Methylprednisolone
Glucocorticoid
Aortic Dissection
Organ Dysfunction
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Amplitude of variation of SOFA score on post-operative day 4 compared to baseline
timeFrame: Within 4 days on admission to CSICU
Secondary outcomes:
measure: In-hospital mortality
timeFrame: Up to 30 days
measure: Duration of ICU stay
timeFrame: Up to 30 days
measure: Duration of mechanical ventilation
timeFrame: Up to 30 days
measure: Duration of hospital stay
timeFrame: Up to 30 days
measure: The proportion of patients receiving RRT
timeFrame: Up to 30 days
measure: The duration of RRT will be compared between two groups.
timeFrame: Up to 30 days
measure: Incidence of Tracheostomy
timeFrame: Up to 30 days
measure: Incidence of Post-operative infection
timeFrame: Up to 30 days
measure: Changes in Inflammation markers
timeFrame: Within 3 days on admission to CSICU
measure: Rate of Composite outcome
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhe Luo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: