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

April 21, 2022 updated by: Jianfang Luo, Guangdong Provincial People's Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Active Comparator: physiological saline group
a single preoperative dose of 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of acute renal failure
Time Frame: the first 5 postoperative days
the rate of acute renal failure in the first 5 postoperative days
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
the first 5 postoperative days
postoperative pain score
Time Frame: 1 hour and 24 hours after thoracic endovascular repair
postoperative pain score
1 hour and 24 hours after thoracic endovascular repair
Rate of all-cause mortality
Time Frame: three months
All-cause mortality includes aortic-related and nonaortic-related mortality
three months
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
three months
Incidence of re-intervention
Time Frame: three months
secondary intervention
three months
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
three months
Incidence of aorta-related adverse events
Time Frame: three months
aortic rupture, aortic-related death, re-intervention and paraplegia
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Collaborators

The First Affiliated Hospital of Guangzhou Medical University
Shenzhen People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-Z-2021-581-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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