Additive Anti-inflammatory Action for Aortopathy & Arteriopathy
ConditionAcute Aortic Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanjing Medical University
About this trial
Acute aortic syndrome (AAS) is a life-threatening condition. Inflammation plays a key role in the pathogenesis, development and progression of AAS, and is associated with significant mortality and morbidity. Understanding the inflammatory responses and inflammation resolutions is essential for an appropriate management of AAS.
Twenty Chinese cardiovascular centers have collaborated to create a multicenter observational registry (named Chinese registry of Additive Anti-inflammatory Action for Aortopathy \& Arteriopathy \[5A\]), with consecutive enrollment of adult patients who underwent surgery for AAS that was started on Jan 1, 2016 and will be ended on December 31, 2040. Specially, the impact of inflammation and anti-inflammatory strategies on the early and late adverse events are investigated. Primary outcomes are severe systemic inflammatory response syndrome (SIRS), multiple organ dysfunction syndrome (MODS), Sequential Organ Failure Assessment (SOFA) scores at 7 days following this current surgery. Secondary outcomes are SISR, 30-day mortality, operative mortality, hospital mortality, new-onset stroke, acute kidney injury, surgical site infection, reoperation for bleeding, blood transfusion and length of stay in the intensive care unit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older.
Patients with diagnosis of AAS, including aortic dissection, penetrating aortic ulcer or intramural hematoma.
Symptoms started within 14 days from surgery.
Patients received medical therapy, open surgical, endovascular, or hybrid repair.
Disqualifiers
Patients aged < 18 years.
Onset of symptoms > 14 days from surgery.
AAS secondary to traumatic or iatrogenic injury.
Patients who declined participation in registration and follow-up investigation.
Trial population
Chinese patients suffering AAS
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
observation
Other interventionData were collected by a designed form. Statistic software was used to analyze clinical data.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Operative mortality
Operative mortality was defined as any death, regardless of cause, occurring whether within 30 days after surgery in or out of the hospital or after 30 days during the same hospitalization subsequent to the operation.
Time frame
30 days after treatment2
Severe systemic inflammatory response syndrome (SIRS)
SIRS was defined as the presence of at least 2 of the 4 age-specific criteria: temperature, heart rate, respiratory rate, and leukocyte count, one of which must be abnormal temperature or leukocyte count. severe SIRS was defined as meeting all 4 aforementioned criteria, measured immediately following surgery through postoperative day 7.
Time frame
7 days after treatmentSponsors and contacts
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Nanjing Medical University
Lead sponsor
Beijing Anzhen Hospital
Collaborator
Source ClinicalTrials.gov