Post Implantation Syndrome and Administration on NSAIDs in Patients Undergoing EVAR for AAA

NCT03727412 | Unknown

• 1 other identifier: 01
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION Post-implantation syndrome is the clinical and biochemical expression of an inflammatory response following endovascular repair of an aortic aneurysm. PIS is mainly a clinical condition associated with the implantation of an endograft and is diagnosed by the presence of fever accompanied by elevated WBC count above normal without any evidence of an infection. The correlation between the type of the endograft placed and the development of PIS may indicate that the inflammatory reaction is due to the material of the endograft itself ( polyester or PTFE ). Based on the results of different studies the type of endograft's material seems to play an important role in PIS development and may have a predictive role for a significant number of patients undergoing endovascular repair of abdominal aortic aneurysm (EVAR). In most studies PIS is considered a benign condition, although it may lead to a more demanding postoperative care characterized by prolonged hospitalization. In an other prospective study patients with PIS were more likely to suffer from an adverse event during the 30 days after the procedure. The occurrence of PIS was the only independent predictor of a MACE ( major cardiovascular events ) or an adverse event during the follow-up period. Current available literature data certainly raise the question of altering current approach and treat patients with PIS by focusing on the reduction of the inflammatory response by administration of steroid or non-steroidal drugs. The aim of the present randomized placebo-controlled study is to evaluate whether the perioperative administration of Naproxen (NPR) an anti-inflammatory drug with a beneficial cardiovascular safety profile in patients with an abdominal aortic aneurysm undergoing endovascular repair could have any effect on the inflammatory response and patients outcome during the first year of follow-up after the surgery. METHOD PIS will be considered as the presence of fever (persisting body temperature \> 38 ° C lasting more than 1 day during hospitalization) and leukocytosis ( white blood cell count \> 12,000 / mL ) with negative blood and urine culture. All patients with AAA that will be subjected to EVAR in our department since February 2018 and who will receive an endograft made from polyester will be included in this study. All patients after being informed pre-operatively about the way and the purpose of the clinical study, the patients will be randomly selected to receive either naproxen ( NPR ) 500 mg x 2 or placebo, starting the previous day before the procedure and for 3 days postoperatively. The NPR was selected due to the expected significant anti-inflammatory activity and favorable cardiovascular safety profile. All patients presenting with fever during the post-operative period, whether or not fulfilling the PIS criteria, will undergo a thorough work up for possible infection. If any of these tests reveal evidence of an early pulmonary, urinary tract or any other kind of infection, the patient will not be considered to suffer from PIS. Patients will be discharged in the absence of any complications, with a body temperature \< 38oC for at least 24 hours and a WBC \< 12.000/mL. Besides the traditional inflammatory markers (WBC, hs-CRP, and fibrinogen ) the investigators will also measure interleukin 6 (IL-6) because it was the only marker significantly altered in PIS patients in a previous study. The follow-up will be performed at 1, and 12 months after surgery. Patient quality of life will also be studied by completing the SF36 questionnaire preoperatively and in the first year post-operative follow-up.

Conditions

Aneurysm Abdominal; Endovacular Repair

Keywords

post implantation syndrome; EVAR; cardiovascular outcome; NSAIDs

Outcome Measures

Primary Outcomes (1)

• major cardiovascular events after endovascular aneurysm repair

  The occurrence of major cardiovascular event (myocardial infarction, stroke, transient ischemic attacks, cardiac arrythmia, congestive heart failure, angina unstable, cardiac death) after EVAR

  2 years

Secondary Outcomes (1)

• post implantation syndrome

  2 years

Study Arms (2)

Naproxen Group

ACTIVE COMPARATOR

patients with an abdominal aortic aneurysm undergoing endovascular epair and taking preoperatively naproxen (Naprosyn, tab 500 mg twice/day for 4 days)

Drug: Drugs, Generic (Naprosyn)

Control group

PLACEBO COMPARATOR

patients with an abdominal aortic aneurysm undergoing endovascular epair and taking placebo

Drug: Placebo Oral Tablet

Interventions

Drugs, Generic (Naprosyn) DRUG

naproxen administration perioperatively in patients with a abdominal aortic aneurysm undergoing endovascular repair

Naproxen Group

Placebo Oral Tablet DRUG

placebo administration perioperatively in patients with a abdominal aortic aneurysm undergoing endovascular repair

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients suffering from infrarenal abdominal aortic aneurysm undergoing endovascular aneurysm repair

You may not qualify if:

• Leukocytosis (white blood cell count \[WBC\]\> 10,000 / mL) and elevated body temperature
• Signs of gangrene
• Previous trauma or surgery two months before enrolling in the study
• Previous implantation of endoprothesis
• Any autoimmune disease or systemic inflammatory condition
• Any malignancy
• Use of anti-inflammatory drugs, chemotherapeutic agents, immunosuppressants or anticoagulants
• Severe severe renal impairment (GFR \< 30 ml / min) and
• Absolute contraindications of NSAIDs such as: NSAID-allergic patients, patients who have experienced asthma attacks following the use of acetylsalicylic acid or other anti-inflammatory nonsteroidal drugs, patients with nasal polyps, patients with anaphylactic or other severe NSAID allergies, severe hepatic insufficiency, heart failure patients (moderate to severe), patients with ischemic heart disease or other vascular diseases, presence of old or active gastric or ulcer of duodenum, history of gastrointestinal haemorrhage in the past, proctitis or recent rectal bleeding, a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease).

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University of Thessaly

Larissa, 41335, Greece

RECRUITING

Related Publications (4)

• 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 RESULT

• Arnaoutoglou E, Kouvelos G, Milionis H, Mavridis A, Kolaitis N, Papa N, Papadopoulos G, Matsagkas M. Post-implantation syndrome following endovascular abdominal aortic aneurysm repair: preliminary data. Interact Cardiovasc Thorac Surg. 2011 Apr;12(4):609-14. doi: 10.1510/icvts.2010.256784. Epub 2011 Jan 19.

  PMID: 21248083 RESULT

• Arnaoutoglou E, Kouvelos G, Papa N, Kallinteri A, Milionis H, Koulouras V, Matsagkas M. Prospective evaluation of post-implantation inflammatory response after EVAR for AAA: influence on patients' 30 day outcome. Eur J Vasc Endovasc Surg. 2015 Feb;49(2):175-83. doi: 10.1016/j.ejvs.2014.12.006. Epub 2015 Jan 9.

  PMID: 25579873 RESULT

• Arnaoutoglou E, Kouvelos G, Papa N, Gartzonika K, Milionis H, Koulouras V, Matsagkas M. Prospective evaluation of postimplantation syndrome evolution on patient outcomes after endovascular aneurysm repair for abdominal aortic aneurysm. J Vasc Surg. 2016 May;63(5):1248-55. doi: 10.1016/j.jvs.2015.11.043. Epub 2016 Feb 28.

  PMID: 26926930 RESULT

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Pharmaceutical Preparations; Drugs, Generic; Naproxen

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Eleni Arnaoutoglou, MD, PhD

CONTACT

+306974301352; earnaout@gmail.com

Maria-Eirini Papadonta, MD

CONTACT

+306937606628; mariaeirini.papadonta@yahoo.it

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: Professor of Anesthesiology

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: August 1, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 26, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)