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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05329740

Collaborator

(none)

212

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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. Eligible patients will be randomly assigned on a 1:1 ratio to the GC group and the control group. Patients in the GC group will receive intravenous methylprednisolone from post-operative day 1 to post-operative day 3, while those in the control group will follow standard treatments. The primary outcome is the area under the curve of SOFA score from baseline(pre-operative) to post-operative day 3.

Condition or Disease	Intervention/Treatment	Phase
Methylprednisolone Glucocorticoid Aortic Dissection Organ Dysfunction	Drug: Methylprednisolone Injection	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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).
No Intervention: Control Group

Arm

Intervention/Treatment

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).

No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

Area under the curve (AUC) of the SOFA score from baseline(on CSICU admission) to post-operative day 3 [Within 3 days on admission to CSICU]

Secondary Outcome Measures

Amplitude of variation of SOFA score on post-operative day 3 compared to baseline [Within 3 days on admission to CSICU]
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 [Up to 30 days]
Use of Renal Replacement Therapy(RRT)
The duration of RRT will be compared between two groups. [Up to 30 days]
Use of Renal Replacement Therapy(RRT)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)
Poorly controlled serum glucose with insulin or hypoglycemic drugs