BNP and Vascular Surgery

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

• Registration Number: NCT03926104
• Lead Sponsor: University of Parma

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 Timeline

• Study Start: 2018-12-10
• Study First Submitted: 2019-01-07
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Study First Posted: 2019-04-24
• Last Update Posted: 2019-04-24
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cardiac events	from the induction of general anesthesia until hospital discharge, an average of 1 week

Secondary Outcome Measures

Name	Time	Method
Incidence of mortality	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 pulmonary 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

Trial Locations

Locations (1)

Elena Giovanna Bignami; 🇮🇹 Parma, Italy