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

NCT05329740 | Completed Phase 4

• 1 other identifier: B2022-030R2
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Methylprednisolone; Glucocorticoid; Aortic Dissection; Organ Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  Within 4 days on admission to CSICU

Secondary Outcomes (10)

• 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

Study Arms (2)

Glucocorticoid group

EXPERIMENTAL

Drug: Methylprednisolone Injection

Control Group

NO INTERVENTION

Interventions

Methylprednisolone Injection 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).

Glucocorticoid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Aortic Dissection

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zhe Luo, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 15, 2022
• Study Start: February 7, 2022
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

CN (1)