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

NCT05349071 | Unknown DMC

• 1 other identifier: KY-Z-2021-581-02
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

type B aortic dissection; post-implantation syndrome; thoracic endovascular repair; methylprednisolone

Outcome Measures

Primary Outcomes (1)

• Rate of post-implantation syndrome

  the incidence of post-implantation syndrome in the first 5 postoperative days

  the first 5 postoperative days

Secondary Outcomes (8)

• Rate of acute renal failure

  the first 5 postoperative days

• Rate of postoperative delirium

  the first 5 postoperative days

• postoperative pain score

  1 hour and 24 hours after thoracic endovascular repair

• Rate of all-cause mortality

  three months

• Rate of aortic-related mortality

  three months

Study Arms (2)

methylprednisolone group

EXPERIMENTAL

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

physiological saline group

ACTIVE COMPARATOR

a single preoperative dose of 250 mL of physiological saline 2 hours before surgery as a 30-minute infusion.

Drug: physiological saline

Interventions

methylprednisolone DRUG

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.

methylprednisolone group

physiological saline DRUG

a single preoperative dose of 250 mL of physiological saline 2 hours before surgery as a 30-minute infusion.

physiological saline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Shenzhen People's Hospital: collaborator

Related Publications (14)

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  PMID: 25173340 BACKGROUND

• 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.

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• 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.

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• 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.

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  PMID: 29066151 BACKGROUND

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  PMID: 21224813 BACKGROUND

• 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.

  PMID: 30521031 BACKGROUND

• 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.

  PMID: 20643821 BACKGROUND

• 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.

  PMID: 30217710 BACKGROUND

• 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.

  PMID: 33105245 BACKGROUND

• 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.

  PMID: 25115430 BACKGROUND

• 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.

  PMID: 27440162 BACKGROUND

• 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.

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MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jianfang Luo, MD

  Guangdong Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Songyuan Luo, MD

CONTACT

+86-13570337597; 656781257@qq.com

Guokui Zhang, MM

CONTACT

+86-13622266656; 772379801@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share