BNP and Vascular Surgery

General Anesthesia Clinical Trial

— BNPinVasc  

Official title:

Evaluation of BNP Values in Major Vascular Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03926104
• Other study ID #: 39751 del 19/10/2018
• Status: Recruiting
• Start date: December 10, 2018
• Est. completion date: December 10, 2020

Study information

• Verified date: April 2019
• Source: University of Parma
• Contact: Elena Giovanna Bignami, MD Professor
• Email: elenagiovanna.bignami[@]unipr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Italy	Elena Giovanna Bignami	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiac events		from the induction of general anesthesia until hospital discharge, an average of 1 week
Secondary	Incidence of postoperative pulmonary complication		from immediately after surgery until hospital discharge, an average of 1 week
Secondary	Incidence of postoperative neurological complication		from immediately after surgery until hospital discharge, an average of 1 week
Secondary	Incidence of postoperative acute kidney failure		from immediately after surgery until hospital discharge, an average of 1 week
Secondary	Incidence of unplanned ICU admission		from immediately after surgery until hospital discharge, an average of 1 week
Secondary	Hospital length of stay		from immediately after surgery until hospital discharge, an average of 1 week
Secondary	Incidence of mortality		from immediately after surgery until hospital discharge, an average of 1 week