BNP and Vascular Surgery

NCT03926104 | Unknown

• 1 other identifier: 39751 del 19/10/2018
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia; Vascular Surgery; Abdominal Aortic Aneurysm; Natriuretic Peptide, Brain; Mets; Preoperative Period; Postoperative Period

Outcome Measures

Primary Outcomes (1)

• Incidence of cardiac events

  from the induction of general anesthesia until hospital discharge, an average of 1 week

Secondary Outcomes (6)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult undergoing major vascular surgery

You may qualify if:

• Ability to provide an informed consent
• Age \>18 years old
• Elective abdominal aortic aneurysm surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Elena Giovanna Bignami

Parma, 43126, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 29332544 BACKGROUND

• 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.

  PMID: 26073822 BACKGROUND

• 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.

  PMID: 24738805 BACKGROUND

• 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.

  PMID: 23058722 BACKGROUND

• 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.

  PMID: 22387082 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Elena Giovanna Bignami, MD Professor

CONTACT

elenagiovanna.bignami@unipr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: April 24, 2019
• Study Start: December 10, 2018
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

IT (1)