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

NCT ID: NCT05329740

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-07

Study Completion Date

2023-11-29

Brief Summary

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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.

Detailed Description

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Conditions

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Methylprednisolone Glucocorticoid Aortic Dissection Organ Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Glucocorticoid group

Group Type EXPERIMENTAL

Methylprednisolone Injection

Intervention Type 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).

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guowei Tu

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhe Luo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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B2022-030R2

Identifier Type: -

Identifier Source: org_study_id