BNP and Vascular Surgery (BNPinVasc)

Evaluation of BNP Values in Major Vascular Surgery

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.

Study Overview

• Status: Unknown
• Conditions: General Anesthesia; Abdominal Aortic Aneurysm; Vascular Surgery; Mets; Preoperative Period; Postoperative Period; Natriuretic Peptide, Brain

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
• Enrollment (Anticipated): 165

Contacts and Locations

• Study Contact: Name: Elena Giovanna Bignami, MD Professor; Email: elenagiovanna.bignami@unipr.it

Study Locations

• Italy
  • Parma, Italy, 43126
    • Recruiting
    • Elena Giovanna Bignami
    • Contact: Elena Giovanna Bignami, MD Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult undergoing major vascular surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of cardiac events	from the induction of general anesthesia until hospital discharge, an average of 1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative pulmonary complication	from immediately after surgery until hospital discharge, an average of 1 week
Incidence of postoperative neurological complication	from immediately after surgery until hospital discharge, an average of 1 week
Incidence of postoperative acute kidney failure	from immediately after surgery until hospital discharge, an average of 1 week
Incidence of unplanned ICU admission	from immediately after surgery until hospital discharge, an average of 1 week
Hospital length of stay	from immediately after surgery until hospital discharge, an average of 1 week
Incidence of mortality	from immediately after surgery until hospital discharge, an average of 1 week

Collaborators and Investigators

• Sponsor: University of Parma

Publications and helpful links

General Publications

• Vetrugno L, Orso D, Matellon C, Giaccalone M, Bove T, Bignami E. The Possible Use of Preoperative Natriuretic Peptides for Discriminating Low Versus Moderate-High Surgical Risk Patient. Semin Cardiothorac Vasc Anesth. 2018 Dec;22(4):395-402. doi: 10.1177/1089253217752061. Epub 2018 Jan 13.
• Wayne Causey M, Singh N. Clinical implications of B-type natriuretic peptide and N-terminal pro--B-type natriuretic peptide in the care of the vascular surgery patient. Semin Vasc Surg. 2014 Dec;27(3-4):143-7. doi: 10.1053/j.semvascsurg.2015.01.004. Epub 2015 Jan 21.
• Biccard BM, Devereaux PJ, Rodseth RN. Cardiac biomarkers in the prediction of risk in the non-cardiac surgery setting. Anaesthesia. 2014 May;69(5):484-93. doi: 10.1111/anae.12635.
• Bryce GJ, Payne CJ, Gibson SC, Byrne DS, Delles C, McClure J, Kingsmore DB. B-type natriuretic peptide predicts postoperative cardiac events and mortality after elective open abdominal aortic aneurysm repair. J Vasc Surg. 2013 Feb;57(2):345-53. doi: 10.1016/j.jvs.2012.07.053. Epub 2012 Oct 9.
• Vetrugno L, Costa MG, Pompei L, Chiarandini P, Drigo D, Bassi F, Gonano N, Muzzi R, Della Rocca G. Prognostic power of pre- and postoperative B-type natriuretic peptide levels in patients undergoing abdominal aortic surgery. J Cardiothorac Vasc Anesth. 2012 Aug;26(4):637-42. doi: 10.1053/j.jvca.2012.01.018. Epub 2012 Mar 2.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Anticipated): December 10, 2020
• Study Completion (Anticipated): December 10, 2020

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 39751 del 19/10/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No