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

NCT05349071 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2022-04-27

No results posted yet for this study

Summary

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.

Conditions

  • Methylprednisolone
  • Thoracic Endovascular Repair
  • Post-implantation Syndrome
  • Type B Aortic Dissection

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Shenzhen People's Hospital

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Jianfang Luo, MD · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-05-01
Completion
2024-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05349071 on ClinicalTrials.gov