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

Primary Purpose

Methylprednisolone, Glucocorticoid, Aortic Dissection

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Methylprednisolone Injection
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methylprednisolone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Glucocorticoid group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

In-hospital mortality
Duration of ICU stay
Duration of mechanical ventilation
Duration of hospital stay
The proportion of patients receiving RRT
Use of Renal Replacement Therapy(RRT)
The duration of RRT will be compared between two groups.
Use of Renal Replacement Therapy(RRT)
Incidence of Tracheostomy
Incidence of Post-operative infection
Changes in Inflammation markers
Inflammation markers include IL-1, IL2R, IL-6 and TNFa
Rate of Composite outcome
In-hospital mortality or Duration of ICU stay longer than 30 days or The need for tracheostomy

Full Information

First Posted
March 30, 2022
Last Updated
March 16, 2023
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05329740
Brief Title
Glucocorticoids for Post-operative Patients With Acute Type A Aortic Dissection (The GLAD Trial)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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(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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methylprednisolone, Glucocorticoid, Aortic Dissection, Organ Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glucocorticoid group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Injection
Intervention Description
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 Outcome Measure Information:
Title
Amplitude of variation of SOFA score on post-operative day 4 compared to baseline
Time Frame
Within 4 days on admission to CSICU
Secondary Outcome Measure Information:
Title
In-hospital mortality
Time Frame
Up to 30 days
Title
Duration of ICU stay
Time Frame
Up to 30 days
Title
Duration of mechanical ventilation
Time Frame
Up to 30 days
Title
Duration of hospital stay
Time Frame
Up to 30 days
Title
The proportion of patients receiving RRT
Description
Use of Renal Replacement Therapy(RRT)
Time Frame
Up to 30 days
Title
The duration of RRT will be compared between two groups.
Description
Use of Renal Replacement Therapy(RRT)
Time Frame
Up to 30 days
Title
Incidence of Tracheostomy
Time Frame
Up to 30 days
Title
Incidence of Post-operative infection
Time Frame
Up to 30 days
Title
Changes in Inflammation markers
Description
Inflammation markers include IL-1, IL2R, IL-6 and TNFa
Time Frame
Within 3 days on admission to CSICU
Title
Rate of Composite outcome
Description
In-hospital mortality or Duration of ICU stay longer than 30 days or The need for tracheostomy
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guowei Tu, MD, PhD
Phone
+86 13501996995
Email
tu.guowei@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jingchao Luo, MD,PhD
Phone
+86 13121021484
Email
luo.jingchao@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhe Luo, MD, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhe Luo, MD
Email
luo.zhe@zs-hospital.sh.cn

12. IPD Sharing Statement

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

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