BNP and Vascular Surgery

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Abdominal aortic aneurysm
Related Access Program
Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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