Brief Title
BNP and Vascular Surgery
Official Title
Evaluation of BNP Values in Major Vascular Surgery
Brief Summary
Background and rationale of the study: Patients undergoing non-cardiac major surgery show a perioperative cardiac risk and postoperative complications, that can be stratified based on parameters linked to patient's conditions and to surgery types. An accurate identification of this risk could offer numerous advantages for these patients, who's 30-day mortality is around 2%. The identification of the correct risk could lead to a better pre- and postoperative management, that could guarantee a better surgery outcome and a faster postoperative recovery. To this day there is no perfect method to correctly estimate this risk. Various studies show that high BNP levels are linked to cardiac events at 30 and 180 days. Further investigations identify different groups, at low, intermediate and high risk, based on BNP levels. BNP is released by ventricular myocytes in response to a wall distress, due to an increased volume, pressure or myocardial ischemia. So BNP plasma levels could be used as a prognostic and diagnostic marker, improving the cardiac risk stratification in patients undergoing surgery and a much more precise management. This study is determined to do an evaluation of the correlations between pre- and postoperative BNP levels and the incidence of cardiac events in patients undergoing major vascular surgery.
Detailed Description
Patient's informed consent signature for adhesion at the study will be initially requested. With their acceptance, parameters will be recorded anonymously in the Case Report Form, identified by their initials and a numeric code, until hospital discharge. The parameters analyzed will be related to: - preoperative evaluation: anamnesis, health general conditions, METs, preoperative monitoring, in particularly BNP basal levels; - intraoperative evaluation: intraoperative monitoring; - postoperative evaluation: BNP and cTnI levels at 24 and 48 hours, and about pulmonary, cardiovascular, neurological and surgical postoperative complications, based on the medical record. The data will be transferred on Excel worksheet, utilized for descriptive analysis related at every variable.
Study Type
Observational
Primary Outcome
Incidence of cardiac events
Secondary Outcome
Incidence of postoperative pulmonary complication
Condition
General Anesthesia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
165
Start Date
December 10, 2018
Completion Date
December 10, 2020
Primary Completion Date
December 10, 2020
Eligibility Criteria
Inclusion Criteria: - Ability to provide an informed consent - Age >18 years old - Elective abdominal aortic aneurysm surgery Exclusion Criteria: - Emergency surgery - Age ˂ 18 years old - Creatinine >2mg/dl - Diseases of ascending aorta, aortic arch or thoracic aorta - Chronic atrial fibrillation - Patient refusal to provide informed consent
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, , [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT03926104
Organization ID
39751 del 19/10/2018
Responsible Party
Principal Investigator
Study Sponsor
University of Parma
Study Sponsor
, ,
Verification Date
April 2019