MethylprednisolonePhase 4NCT05329740
Glucocorticoids for Post-operative Patients With Acute Type A Aortic Dissection (The GLAD Trial)
A Phase 4 study testing Methylprednisolone Injection in people with Methylprednisolone and Glucocorticoid, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methylprednisolone, Glucocorticoid, Aortic Dissection
- What is being tested?
- Methylprednisolone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2022to 29 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Methylprednisolone Injection
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone InjectionDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoid group | Experimental | Not described Receives: Drug: Methylprednisolone Injection |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of variation of SOFA score on post-operative day 4 compared to baseline
Measured: Within 4 days on admission to CSICU
Secondary outcomes (10)
In-hospital mortality
Measured: Up to 30 days
Duration of ICU stay
Measured: Up to 30 days
Duration of mechanical ventilation
Measured: Up to 30 days
Duration of hospital stay
Measured: Up to 30 days
The proportion of patients receiving RRT
Use of Renal Replacement Therapy(RRT)
Measured: Up to 30 days
The duration of RRT will be compared between two groups.
Use of Renal Replacement Therapy(RRT)
Measured: Up to 30 days
Incidence of Tracheostomy
Measured: Up to 30 days
Incidence of Post-operative infection
Measured: Up to 30 days
Changes in Inflammation markers
Inflammation markers include IL-1, IL2R, IL-6 and TNFa
Measured: Within 3 days on admission to CSICU
Rate of Composite outcome
In-hospital mortality or Duration of ICU stay longer than 30 days or The need for tracheostomy
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start7 Feb 2022
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MethylprednisoloneStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guowei Tu, Shanghai Zhongshan Hospital
- Investigators
- Zhe Luo, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329740
- Sponsor's protocol ID
- B2022-030R2
- Status last verified
- Dec 2023
- First submitted
- 30 Mar 2022
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05329740
- Acronym / sponsor ID
- B2022-030R2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoid group | Experimental | Drug: Methylprednisolone Injection |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone InjectionAll 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). | Drug | Glucocorticoid group |
Primary outcome
Amplitude of variation of SOFA score on post-operative day 4 compared to baseline
Time frame: Within 4 days on admission to CSICU
10 secondary outcomes
In-hospital mortality
Time frame: Up to 30 days
Duration of ICU stay
Time frame: Up to 30 days
Duration of mechanical ventilation
Time frame: Up to 30 days
Duration of hospital stay
Time frame: Up to 30 days
The proportion of patients receiving RRT
Time frame: Up to 30 days
The duration of RRT will be compared between two groups.
Time frame: Up to 30 days
Incidence of Tracheostomy
Time frame: Up to 30 days
Incidence of Post-operative infection
Time frame: Up to 30 days
Changes in Inflammation markers
Time frame: Within 3 days on admission to CSICU
Rate of Composite outcome
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhe Luo, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone Injection in people with Methylprednisolone and Glucocorticoid, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of variation of SOFA score on post-operative day 4 compared to baseline (time frame: Within 4 days on admission to CSICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.