Post Implantation Syndrome and Administration on NSAIDs in Patients Undergoing EVAR for AAA
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|ClinicalTrials.gov Identifier: NCT03727412|
Recruitment Status : Unknown
Verified November 2018 by Elena Arnaoutoglou, University of Thessaly.
Recruitment status was: Recruiting
First Posted : November 1, 2018
Last Update Posted : November 26, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- post implantation syndrome [ Time Frame: 2 years ]the occurence of postimplantation syndrome after EVAR
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
|Contact: Eleni Arnaoutoglou, MD, PhDfirstname.lastname@example.org|
|Contact: Maria-Eirini Papadonta, MDemail@example.com|
|University of Thessaly||Recruiting|
|Larissa, Greece, 41335|
|Contact: Eleni Arnaoutoglou, MD, PhD +306974301352 firstname.lastname@example.org|
|Contact: Maria-Eirini Papadonta, MD +306937606628 email@example.com|
|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|