Clinical trial

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

Name

B2022-030R2

Description

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.

Trial arms

Trial start

2022-02-07

Estimated PCD

2023-11-29

Trial end

2023-11-29

Status

Completed

Phase

Early phase I

Treatment

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).

Arms:

Glucocorticoid group

Size

212

Primary endpoint

Amplitude of variation of SOFA score on post-operative day 4 compared to baseline

Within 4 days on admission to CSICU

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 212, 'type': 'ACTUAL'}}

Updated at

2023-12-26

1 organization

1 product

4 indications

Organization

Shanghai Zhongshan Hospital

Product

Indication

Indication

Indication

Indication