PreOperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome (POMTEVAR)
Primary Purpose
Methylprednisolone, Thoracic Endovascular Repair, Post-implantation Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
methylprednisolone
physiological saline
Sponsored by
About this trial
This is an interventional prevention trial for Methylprednisolone focused on measuring type B aortic dissection, post-implantation syndrome, thoracic endovascular repair, methylprednisolone
Eligibility Criteria
Inclusion Criteria:
- Age >18 years;
- Be confirmed as Stanford type B aortic dissection by aorta computed tomography;
- From onset to first clinical attach <90 days;
- The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form;
- Availability for the appropriate follow-up visits during the follow-up period;
- Capability to follow all study requirements.
Exclusion Criteria:
- Laboratory examination in the last 3 months suggested severe renal dysfunction (serum creatinine >176.8umol/L or estimated creatinine clearance eGFR <30ml/min;
- Laboratory examination in the last 3 months suggested severe liver dysfunction (ALT> 2x Max or TBIL> 2x Max);
- Diabetics with poor glycemic control: fasting blood glucose ≥13.9mmol/L or hBA1c ≥8.5%;
- Severe hypokalemia (Serum potassium ion concentration was less than 2.5mmol/L);
- HIV positive, hepatitis B or C positive;
- Immune inflammatory diseases (except skin and respiratory diseases that can be treated locally);
- Glaucoma;
- Gastric or duodenal ulcer;
- Active infection (persisting body temperature >38℃; etiological evidence or imaging evidence);
- On immunosuppressive therapy;
- Patients with malignant tumor whose life expectancy is less than 1 year;
- Genetic diseases, including Turner syndrome, Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome and other connective tissue diseases;
- Rheumatic immune diseases, including multiple arteritis, giant cell arteritis, polyarteritis nodosum, etc;
- Pregnant women;
- Severe mental illness;
- Poor compliance, difficult to cooperate with follow-up;
- 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;
- Any conditions or laboratory findings that the investigator considers inappropriate for inclusion.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
methylprednisolone group
physiological saline group
Arm Description
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.
a single preoperative dose of 250 mL of physiological saline 2 hours before surgery as a 30-minute infusion.
Outcomes
Primary Outcome Measures
Rate of post-implantation syndrome
the incidence of post-implantation syndrome in the first 5 postoperative days
Secondary Outcome Measures
Rate of acute renal failure
the rate of acute renal failure in the first 5 postoperative days
Rate of postoperative delirium
the rate of postoperative delirium in the first 5 postoperative days
postoperative pain score
postoperative pain score
Rate of all-cause mortality
All-cause mortality includes aortic-related and nonaortic-related mortality
Rate of aortic-related mortality
Aortic-related death was defined as death attributable to an aortic cause during the initial admission or follow-up
Incidence of re-intervention
secondary intervention
Incidence of major adverse cardiovascular events
cardiac death, non-fatal acute myocardial infarction (ST and non-ST), ischemic stroke or transient ischemic attack
Incidence of aorta-related adverse events
aortic rupture, aortic-related death, re-intervention and paraplegia
Full Information
NCT ID
NCT05349071
First Posted
April 21, 2022
Last Updated
April 21, 2022
Sponsor
Guangdong Provincial People's Hospital
Collaborators
The First Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05349071
Brief Title
PreOperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome (POMTEVAR)
Official Title
Preoperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
Collaborators
The First Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methylprednisolone, Thoracic Endovascular Repair, Post-implantation Syndrome, Type B Aortic Dissection
Keywords
type B aortic dissection, post-implantation syndrome, thoracic endovascular repair, methylprednisolone
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
methylprednisolone group
Arm Type
Experimental
Arm Description
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.
Arm Title
physiological saline group
Arm Type
Active Comparator
Arm Description
a single preoperative dose of 250 mL of physiological saline 2 hours before surgery as a 30-minute infusion.
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
physiological saline
Intervention Description
a single preoperative dose of 250 mL of physiological saline 2 hours before surgery as a 30-minute infusion.
Primary Outcome Measure Information:
Title
Rate of post-implantation syndrome
Description
the incidence of post-implantation syndrome in the first 5 postoperative days
Time Frame
the first 5 postoperative days
Secondary Outcome Measure Information:
Title
Rate of acute renal failure
Description
the rate of acute renal failure in the first 5 postoperative days
Time Frame
the first 5 postoperative days
Title
Rate of postoperative delirium
Description
the rate of postoperative delirium in the first 5 postoperative days
Time Frame
the first 5 postoperative days
Title
postoperative pain score
Description
postoperative pain score
Time Frame
1 hour and 24 hours after thoracic endovascular repair
Title
Rate of all-cause mortality
Description
All-cause mortality includes aortic-related and nonaortic-related mortality
Time Frame
three months
Title
Rate of aortic-related mortality
Description
Aortic-related death was defined as death attributable to an aortic cause during the initial admission or follow-up
Time Frame
three months
Title
Incidence of re-intervention
Description
secondary intervention
Time Frame
three months
Title
Incidence of major adverse cardiovascular events
Description
cardiac death, non-fatal acute myocardial infarction (ST and non-ST), ischemic stroke or transient ischemic attack
Time Frame
three months
Title
Incidence of aorta-related adverse events
Description
aortic rupture, aortic-related death, re-intervention and paraplegia
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years;
Be confirmed as Stanford type B aortic dissection by aorta computed tomography;
From onset to first clinical attach <90 days;
The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form;
Availability for the appropriate follow-up visits during the follow-up period;
Capability to follow all study requirements.
Exclusion Criteria:
Laboratory examination in the last 3 months suggested severe renal dysfunction (serum creatinine >176.8umol/L or estimated creatinine clearance eGFR <30ml/min;
Laboratory examination in the last 3 months suggested severe liver dysfunction (ALT> 2x Max or TBIL> 2x Max);
Diabetics with poor glycemic control: fasting blood glucose ≥13.9mmol/L or hBA1c ≥8.5%;
Severe hypokalemia (Serum potassium ion concentration was less than 2.5mmol/L);
HIV positive, hepatitis B or C positive;
Immune inflammatory diseases (except skin and respiratory diseases that can be treated locally);
Glaucoma;
Gastric or duodenal ulcer;
Active infection (persisting body temperature >38℃; etiological evidence or imaging evidence);
On immunosuppressive therapy;
Patients with malignant tumor whose life expectancy is less than 1 year;
Genetic diseases, including Turner syndrome, Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome and other connective tissue diseases;
Rheumatic immune diseases, including multiple arteritis, giant cell arteritis, polyarteritis nodosum, etc;
Pregnant women;
Severe mental illness;
Poor compliance, difficult to cooperate with follow-up;
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;
Any conditions or laboratory findings that the investigator considers inappropriate for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songyuan Luo, MD
Phone
+86-13570337597
Email
656781257@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guokui Zhang, MM
Phone
+86-13622266656
Email
772379801@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfang Luo, MD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25173340
Citation
Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger 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. No abstract available. Erratum In: Eur Heart J. 2015 Nov 1;36(41):2779.
Results Reference
background
PubMed Identifier
29106452
Citation
Bossone E, LaBounty TM, Eagle KA. Acute aortic syndromes: diagnosis and management, an update. Eur Heart J. 2018 Mar 1;39(9):739-749d. doi: 10.1093/eurheartj/ehx319.
Results Reference
background
PubMed Identifier
29685932
Citation
Evangelista A, Isselbacher EM, Bossone E, Gleason TG, Eusanio MD, Sechtem U, Ehrlich MP, Trimarchi S, Braverman AC, Myrmel T, Harris KM, Hutchinson S, O'Gara P, Suzuki T, Nienaber CA, Eagle KA; IRAD Investigators. Insights From the International Registry of Acute Aortic Dissection: A 20-Year Experience of Collaborative Clinical Research. Circulation. 2018 Apr 24;137(17):1846-1860. doi: 10.1161/CIRCULATIONAHA.117.031264.
Results Reference
background
PubMed Identifier
32927144
Citation
Liu D, Luo H, Lin S, Zhao L, Qiao C. Comparison of the efficacy and safety of thoracic endovascular aortic repair with open surgical repair and optimal medical therapy for acute type B aortic dissection: A systematic review and meta-analysis. Int J Surg. 2020 Nov;83:53-61. doi: 10.1016/j.ijsu.2020.08.051. Epub 2020 Sep 11.
Results Reference
background
PubMed Identifier
29066151
Citation
Li FR, Wu X, Yuan J, Wang J, Mao C, Wu X. Comparison of thoracic endovascular aortic repair, open surgery and best medical treatment for type B aortic dissection: A meta-analysis. Int J Cardiol. 2018 Jan 1;250:240-246. doi: 10.1016/j.ijcard.2017.10.050. Epub 2017 Oct 16.
Results Reference
background
PubMed Identifier
21224813
Citation
De La Motte L, Vogt K, Panduro Jensen L, Groenvall J, Kehlet H, Veith Schroeder T, Lonn L. Incidence of systemic inflammatory response syndrome after endovascular aortic repair. J Cardiovasc Surg (Torino). 2011 Feb;52(1):73-9.
Results Reference
background
PubMed Identifier
30521031
Citation
Zhu Y, Luo S, Ding H, Liu Y, Huang W, Xie N, Li J, Xue L, Luo J. Predictors associated with an increased prevalence of postimplantation syndrome after thoracic endovascular aortic repair for type B aortic dissectiondagger. Eur J Cardiothorac Surg. 2019 May 1;55(5):998-1005. doi: 10.1093/ejcts/ezy379.
Results Reference
background
PubMed Identifier
20643821
Citation
Arnaoutoglou E, Papas N, Milionis H, Kouvelos G, Koulouras V, Matsagkas MI. Post-implantation syndrome after endovascular repair of aortic aneurysms: need for postdischarge surveillance. Interact Cardiovasc Thorac Surg. 2010 Oct;11(4):449-54. doi: 10.1510/icvts.2010.242628. Epub 2010 Jul 19.
Results Reference
background
PubMed Identifier
30217710
Citation
Belkin N, Jackson BM, Foley PJ, Damrauer SM, Kalapatapu V, Golden MA, Fairman RM, Kelz RR, Wang GJ. Length of Stay after Thoracic Endovascular Aortic Repair Depends on Indication and Acuity. Ann Vasc Surg. 2019 Feb;55:157-165. doi: 10.1016/j.avsg.2018.06.027. Epub 2018 Sep 11.
Results Reference
background
PubMed Identifier
33105245
Citation
Chan TCW, Cheung CW, Wong SSC, Chung AYF, Irwin MG, Chan PK, Fu H, Yan CH, Chiu KY. Preoperative dexamethasone for pain relief after total knee arthroplasty: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1157-1167. doi: 10.1097/EJA.0000000000001372.
Results Reference
background
PubMed Identifier
25115430
Citation
de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lonn 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.
Results Reference
background
PubMed Identifier
27440162
Citation
Nienaber CA, Clough RE, Sakalihasan N, Suzuki T, Gibbs R, Mussa F, Jenkins MP, Thompson MM, Evangelista A, Yeh JS, Cheshire N, Rosendahl U, Pepper J. Aortic dissection. Nat Rev Dis Primers. 2016 Jul 21;2:16053. doi: 10.1038/nrdp.2016.53.
Results Reference
background
PubMed Identifier
30312382
Citation
Czerny M, Schmidli J, Adler S, van den Berg JC, Bertoglio L, Carrel T, Chiesa R, Clough RE, Eberle B, Etz C, Grabenwoger M, Haulon S, Jakob H, Kari FA, Mestres CA, Pacini D, Resch T, Rylski B, Schoenhoff F, Shrestha M, von Tengg-Kobligk H, Tsagakis K, Wyss TR; EACTS/ESVS scientific document group. Current options and recommendations for the treatment of thoracic aortic pathologies involving the aortic arch: an expert consensus document of the European Association for Cardio-Thoracic surgery (EACTS) and the European Society for Vascular Surgery (ESVS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):133-162. doi: 10.1093/ejcts/ezy313. No abstract available.
Results Reference
background
PubMed Identifier
30480776
Citation
Polderman JA, Farhang-Razi V, Van Dieren S, Kranke P, DeVries JH, Hollmann MW, Preckel B, Hermanides J. Adverse side effects of dexamethasone in surgical patients. Cochrane Database Syst Rev. 2018 Nov 23;11(11):CD011940. doi: 10.1002/14651858.CD011940.pub3.
Results Reference
background
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PreOperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome (POMTEVAR)
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