PreOperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome (POMTEVAR)

Overview

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.

Full Title of Study: “Preoperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2024

Detailed Description

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. TEVAR plus glucocorticoids group: Patients receive a single preoperative dose of 500 mg of methylprednisolone diluted in 250 mL of physiological saline 2 hours before TEVAR as a 30-minute infusion. TEVAR alone group: Patients receive a single preoperative dose of 250 mL of physiological saline 2 hours before TEVAR as a 30-minute infusion. TEVAR steps:According to the preoperative imaging, the potential risk location of the aortic dissection or rupture and the extent of lesion involvement are evaluated, and the appropriate anchoring zone is selected to ensure a sufficient anchorage area of more than 15 mm. If the distance between the potential accident site and the left subclavian artery (LSA) is less than 15 mm, LSA will be covered to obtain sufficient anchoring area. LSA revascularization will be performed by chimney technique or hybrid operation, depending on the choice of the surgeon. The left femoral artery is punctured or cut, the 5F artery sheath is inserted, and the pigtail catheter is inserted into the ascending aorta along the sheath. Next, the aortic covered stent was implanted reverse through the femoral artery under the guidance of the wire. When the stent was released, rapid pacing or intravenous antihypertensive drugs was used to ensure that the blood pressure was lower than 90 mmHg. After stent implantation, re-angiography to confirm the stent location and blood flow, which will indicate whether the operation was successful or not. After all above, the patients will be observed in hospital for at least 3 days. Controls of the blood pressure and heart rate and relief of the symptoms will meet the discharge criteria.

Interventions

  • Drug: methylprednisolone
    • a single preoperative dose of 500 mg of methylprednisolone diluted in 250 mL of physiological saline 2 hours before surgery as a 30-minute infusion.
  • Drug: physiological saline
    • a single preoperative dose of 250 mL of physiological saline 2 hours before surgery as a 30-minute infusion.

Arms, Groups and Cohorts

  • Experimental: methylprednisolone group
    • a single preoperative dose of 500 mg of methylprednisolone diluted in 250 mL of physiological saline 2 hours before surgery as a 30-minute infusion.
  • Active Comparator: physiological saline group
    • a single preoperative dose of 250 mL of physiological saline 2 hours before surgery as a 30-minute infusion.

Clinical Trial Outcome Measures

Primary Measures

  • Rate of post-implantation syndrome
    • Time Frame: the first 5 postoperative days
    • the incidence of post-implantation syndrome in the first 5 postoperative days

Secondary Measures

  • Rate of acute renal failure
    • Time Frame: the first 5 postoperative days
    • the rate of acute renal failure in the first 5 postoperative days
  • Rate of postoperative delirium
    • Time Frame: the first 5 postoperative days
    • the rate of postoperative delirium in the first 5 postoperative days
  • postoperative pain score
    • Time Frame: 1 hour and 24 hours after thoracic endovascular repair
    • postoperative pain score
  • Rate of all-cause mortality
    • Time Frame: three months
    • All-cause mortality includes aortic-related and nonaortic-related mortality
  • Rate of aortic-related mortality
    • Time Frame: three months
    • Aortic-related death was defined as death attributable to an aortic cause during the initial admission or follow-up
  • Incidence of re-intervention
    • Time Frame: three months
    • secondary intervention
  • Incidence of major adverse cardiovascular events
    • Time Frame: three months
    • cardiac death, non-fatal acute myocardial infarction (ST and non-ST), ischemic stroke or transient ischemic attack
  • Incidence of aorta-related adverse events
    • Time Frame: three months
    • aortic rupture, aortic-related death, re-intervention and paraplegia

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangdong Provincial People’s Hospital
  • Collaborator
    • The First Affiliated Hospital of Guangzhou Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jianfang Luo, chief physician – Guangdong Provincial People’s Hospital
  • Overall Official(s)
    • Jianfang Luo, MD, Study Chair, Guangdong Provincial People’s Hospital
  • Overall Contact(s)
    • Songyuan Luo, MD, +86-13570337597, 656781257@qq.com

References

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