Type B Aortic Dissection Clinical Trial
Official title:
Preoperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome
POMTEVAR trial is a multicenter, open-label and prospective random controlled study. Approximately 158 patients will be randomly allocated to thoracic endovascular repair (TEVAR) alone group or TEVAR plus methylprednisolone group and managed with respective treatment strategies. All study patients will be followed up in the outpatient clinic and undergo CT scans after 3 months from randomization. The primary objective is to test the hypothesis that PIS is lower in TEVAR plus methylprednisolone group than that in TEVAR alone group. The secondary objective is to test the hypothesis that changes of postoperative inflammatory indicators, incidence of postoperative acute renal failure and postoperative delirium, postoperative pain score are lower in TEVAR plus methylprednisolone group than that in TEVAR alone. In addition, 3-month all-cause death, 3-month major adverse cardiovascular events, 3-month aorta-related adverse events and 3-month aortic remodeling are compared between groups.
Status | Not yet recruiting |
Enrollment | 158 |
Est. completion date | October 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age >18 years; 2. Be confirmed as Stanford type B aortic dissection by aorta computed tomography; 3. From onset to first clinical attach <90 days; 4. The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form; 5. Availability for the appropriate follow-up visits during the follow-up period; 6. Capability to follow all study requirements. Exclusion Criteria: 1. Laboratory examination in the last 3 months suggested severe renal dysfunction (serum creatinine >176.8umol/L or estimated creatinine clearance eGFR <30ml/min; 2. Laboratory examination in the last 3 months suggested severe liver dysfunction (ALT> 2x Max or TBIL> 2x Max); 3. Diabetics with poor glycemic control: fasting blood glucose =13.9mmol/L or hBA1c =8.5%; 4. Severe hypokalemia (Serum potassium ion concentration was less than 2.5mmol/L); 5. HIV positive, hepatitis B or C positive; 6. Immune inflammatory diseases (except skin and respiratory diseases that can be treated locally); 7. Glaucoma; 8. Gastric or duodenal ulcer; 9. Active infection (persisting body temperature >38?; etiological evidence or imaging evidence); 10. On immunosuppressive therapy; 11. Patients with malignant tumor whose life expectancy is less than 1 year; 12. Genetic diseases, including Turner syndrome, Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome and other connective tissue diseases; 13. Rheumatic immune diseases, including multiple arteritis, giant cell arteritis, polyarteritis nodosum, etc; 14. Pregnant women; 15. Severe mental illness; 16. Poor compliance, difficult to cooperate with follow-up; 17. Participate in another investigationdrug or medical device study or another investigationstudy of an approved drug or medical device within 30 days prior to the first visit of the current study; 18. Any conditions or laboratory findings that the investigator considers inappropriate for inclusion. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Guangdong Provincial People's Hospital | Shenzhen People's Hospital, The First Affiliated Hospital of Guangzhou Medical University |
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de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lönn L. Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial. Ann Surg. 2014 Sep;260(3):540-8; discussion 548-9. doi: 10.1097/SLA.0000000000000895. — View Citation
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Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwöger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014 Nov 1;35(41):2873-926. doi: 10.1093/eurheartj/ehu281. Epub 2014 Aug 29. Erratum in: Eur Heart J. 2015 Nov 1;36(41):2779. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of post-implantation syndrome | the incidence of post-implantation syndrome in the first 5 postoperative days | the first 5 postoperative days | |
Secondary | Rate of acute renal failure | the rate of acute renal failure in the first 5 postoperative days | the first 5 postoperative days | |
Secondary | Rate of postoperative delirium | the rate of postoperative delirium in the first 5 postoperative days | the first 5 postoperative days | |
Secondary | postoperative pain score | postoperative pain score | 1 hour and 24 hours after thoracic endovascular repair | |
Secondary | Rate of all-cause mortality | All-cause mortality includes aortic-related and nonaortic-related mortality | three months | |
Secondary | Rate of aortic-related mortality | Aortic-related death was defined as death attributable to an aortic cause during the initial admission or follow-up | three months | |
Secondary | Incidence of re-intervention | secondary intervention | three months | |
Secondary | Incidence of major adverse cardiovascular events | cardiac death, non-fatal acute myocardial infarction (ST and non-ST), ischemic stroke or transient ischemic attack | three months | |
Secondary | Incidence of aorta-related adverse events | aortic rupture, aortic-related death, re-intervention and paraplegia | three months |
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