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NCT Number: NCT05329740

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

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.

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Key information

Conditions

Methylprednisolone Acute Aortic Syndrome Aneurysm Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Glucocorticoid Organ Dysfunction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

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

    Time frame: Within 4 days on admission to CSICU

Secondary outcomes

  1. In-hospital mortality

    Time frame: Up to 30 days

  2. Duration of ICU stay

    Time frame: Up to 30 days

  3. Duration of mechanical ventilation

    Time frame: Up to 30 days

  4. Duration of hospital stay

    Time frame: Up to 30 days

  5. The proportion of patients receiving RRT

    Time frame: Up to 30 days

    Use of Renal Replacement Therapy(RRT)

  6. The duration of RRT will be compared between two groups.

    Time frame: Up to 30 days

    Use of Renal Replacement Therapy(RRT)

  7. Incidence of Tracheostomy

    Time frame: Up to 30 days

  8. Incidence of Post-operative infection

    Time frame: Up to 30 days

  9. Changes in Inflammation markers

    Time frame: Within 3 days on admission to CSICU

    Inflammation markers include IL-1, IL2R, IL-6 and TNFa

  10. Rate of Composite outcome

    Time frame: Up to 30 days

    In-hospital mortality or Duration of ICU stay longer than 30 days or The need for tracheostomy

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2022
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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