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

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ClinicalTrials.gov Identifier: NCT03727412
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Elena Arnaoutoglou, University of Thessaly

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.


Condition or disease Intervention/treatment Phase
Aneurysm Abdominal Endovacular Repair Drug: Drugs, Generic (Naprosyn) Drug: Placebo Oral Tablet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Post Implantation Syndrome and Administration on NSAIDs in Patients Undergoing Endovascular Repair of an Abdominal Aortic Aneurysm Under General Anesthesia
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Naproxen Group
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)
naproxen administration perioperatively in patients with a abdominal aortic aneurysm undergoing endovascular repair

Placebo Comparator: Control group
patients with an abdominal aortic aneurysm undergoing endovascular epair and taking placebo
Drug: Placebo Oral Tablet
placebo administration perioperatively in patients with a abdominal aortic aneurysm undergoing endovascular repair




Primary Outcome Measures :
  1. major cardiovascular events after endovascular aneurysm repair [ Time Frame: 2 years ]
    The occurrence of major cardiovascular event (myocardial infarction, stroke, transient ischemic attacks, cardiac arrythmia, congestive heart failure, angina unstable, cardiac death) after EVAR


Secondary Outcome Measures :
  1. post implantation syndrome [ Time Frame: 2 years ]
    the occurence of postimplantation syndrome after EVAR



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727412


Contacts
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Contact: Eleni Arnaoutoglou, MD, PhD +306974301352 earnaout@gmail.com
Contact: Maria-Eirini Papadonta, MD +306937606628 mariaeirini.papadonta@yahoo.it

Locations
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Greece
University of Thessaly Recruiting
Larissa, Greece, 41335
Contact: Eleni Arnaoutoglou, MD, PhD    +306974301352    earnaout@gmail.com   
Contact: Maria-Eirini Papadonta, MD    +306937606628    mariaeirini.papadonta@yahoo.it   
Principal Investigator: Eleni Arnaoutoglou, MD, PhD         
Sub-Investigator: Maria-Eirini Papadonta, MD         
Sub-Investigator: Petroula Nana, MD         
Sub-Investigator: George Kouvelos, MD, MSc, PhD         
Sub-Investigator: Konstantinos Stamoulis, MD, PhD         
Sub-Investigator: Athanasios Giannoukas, MD, MSc, PhD         
Sub-Investigator: Miltiadis Matsagkas, MD, PhD         
Sponsors and Collaborators
University of Thessaly

Publications of Results:
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Responsible Party: Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier: NCT03727412     History of Changes
Other Study ID Numbers: 01
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elena Arnaoutoglou, University of Thessaly:
post implantation syndrome
EVAR
cardiovascular outcome
NSAIDs
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Aortic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action