Steroid Treatment to Prevent Thoracic Endovascular Aortic Repair Postimplantation Syndrome

ConditionsPostimplantation Syndrome Myocardial Injury MACE Mortality

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-90

SponsorUniversity of Belgrade

About this trial

Postimplantation syndrome (PIS) is a common and clinically important complication following thoracic endovascular aortic repair (TEVAR). PIS is characterized by a strong systemic inflammatory response to the stent-graft implantation and is manifested by flu-like symptoms, which include fever, increased white blood count, increased levels of acute phase proteins, and fatigue, but without a clear inflammatory and infective cause. Besides, it has been demonstrated that PIS is associated with prolonged hospital stay and increased risk for postoperative complications, including acute kidney injury, postoperative delirium, and increased postoperative pain scores. Recently, there has been increasing evidence that PIS is associated with an increased risk of major adverse cardiac events (MACE) and perioperative myocardial injury. Observational studies suggest that preoperative administration of glucocorticoids may decrease the incidence of PIS after TEVAR and EVAR procedures. However, to date, there are no randomised trials that have investigated whether preoperative administration of glucocorticoids can reduce the incidence of PIS and its associated poorer treatment outcomes following TEVAR. This randomized controlled trial was designed to investigate the effect of glucocorticoid administration on reducing the incidence and improving the outcome of patients who develop PIS after TEVAR.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Consecutive patients admitted due to endovascular treatment of aortic dissection type B or thoracoabdominal aortic aneurysm in whom elective, open repair is planned.

Patients capable of giving informed consent.

Patients who are estimated to be available for long-term follow-up.

Disqualifiers

emergency procedures, the existence of severe renal insufficiency (serum creatinine >176 µmol/L or estimated glomerular filtration rate < 30 mL/min/1.73 m2), severe liver insufficiency (ALT value more than twice the upper limit or bilirubin levels more than twice the reference values), uncontrolled diabetes mellitus (fasting glycemia above 13.9 mmol/L, i.e. the value glycosylated hemoglobin over 8.5%), existence of active infection or sepsis, autoimmune disease, chronic pain syndromes, proven allergy to methylprednisolone, existence of gastric or duodenal ulcer, immunosuppressive or chemotherapy in the previous three months, active malignant disease, genetic diseases of connective tissue, pregnancy, critical lower limb ischemia, previous endovascular procedure on the aorta, preoperative administration of corticosteroids for any reason, significantly impaired cognitive status or psychiatric illness, acute peri/myocarditis, advanced heart failure, as well as voluntary refusal to participate in the study

Trial design

Design model

Parallel

Treatments tested in this trial

Methylprednisolone (MP)
Drug
Patients in the MP group would receive 30 mg/kg of methylprednisolone, dissolved in 100 mL of saline, via a 30-minute slow intravenous infusion.
Placebo (saline)
Drug
Patients randomized to the placebo group would receive 100 mL of physiological solution two hours prior to the intervention.

Treatment groups

174 Participants

are divided into 2 treatment groups

Group A: MP (experimental group)Experimental treatment 1 intervention

Group B: Control group (placebo)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of PIS

Post-implantation syndrome would be defined as the occurrence of elevated body temperature (\>38.0°C), with the presence of leukocytosis (\>12,000/mm³), and an increase in the level of C-reactive protein (\>10g/L) during the first five days postoperatively, despite negative blood cultures.

Time frame

5 days postoperatively

Secondary outcomes

incidence of myocardial injury

Myocardial injury would be defined as an increase in the level of hs-TnI above the 99th percentile of the upper reference limitwithout clinical signs of acute myocardial ischemia, during the first three postoperative days.

Time frame

first 3 days postoperatively

incidence of MACE

MACE events would be defined as a composite outcome that includes the occurrence of myocardial infarction, acute heart failure, malignant rhythm disorders, and cardiovascular death during two years after TEVAR.

Time frame

2 years postoperatively

intensity of postoperative pain

The intensity of postoperative pain will be measured using the Numeric Rating Scale - NRS, during 48 hours postoperatively.

Time frame

two days postoperatively

degree of aortic remodeling

Degree of aortic remodeling will be assessed based on CT evaluation of the aorta) one month and two years after TEVAR

Time frame

one month and two years postoperatively

Other outcomes

surgical complications

Postoperative surgical complications will be defined as complications related to the surgical procedure within 30 days after the operation.

Time frame

30 days after TEVAR

non-surgical complications

Postoperative non-surgical complications will be defined as complications which are not related to surgical procedures/techniques and are related to patients' physiological status or comorbidities.

Time frame

30-days after TEVAR

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Belgrade

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: