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Methylprednisolone for acute type A aortic dissection patients ongoing total arch replacement trial(MEDAL trial)

Methylprednisolone for acute type A aortic dissection patients ongoing total arch replacement trial(MEDAL trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059286
Enrollment
Unknown
Registered
2022-04-28
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aortic dissection

Interventions

Steriods group:During the induction of anesthesia, 10ml of sterilized water for injection dissolved with 500mg methylprednisone (Pfizer manufacturing Belgium NY) is injected intravenously
placebo group:During the induction of anesthesia, 10ml of sterilized water for injection is injected intravenously

Sponsors

Chinses Academy of Medical Sciences, Fuwai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old; 2. Patients with acute type A aortic dissection; 3. Emergency total aortic arch replacement: 4. During the operation, hypothermic circulatory arrest combined with selective cerebral perfusion was used; 5. Get the informed consent of the subject or his guardian.

Exclusion criteria

Exclusion criteria: 1. There were neurological deficits before operation; 2. Preoperative arterial blood gas PaO2/FiO2 = 200mmHg; 3. Patients with a history of bacterial or fungal infection 30 days before inclusion in the study; 4. Patients who are allergic or intolerant to glucocorticoids; 5. Patients who must use glucocorticoids due to their illness; 6. Other conditions judged by the researcher as unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence of vital organ injury within 30 days after operation (or before discharge);

Secondary

MeasureTime frame
Postoperative neulogic defict;Postoperative acute kidney injury(KDIGO II -III);Postoperaitve respiratory syndrome;Postoperative acutekidney injury;postoperative renal replacement therapy;Postoperative use of IABP/ECMO;chest drainage in 24hours postoperatively;re-thoratomy;allogenetic transfusion;Mechanical ventilation time;ICU duration;Hospital stay;Infection;wound unhealed;gastrointestinal bleeding/perforation;Intraoperative/postoperative insulin use;

Countries

China

Contacts

Public ContactJi Bingyang

Chinses Academy of Medical Sciences, Fuwai Hospital

jibingyang@fuwai.com+86 13801251767

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026