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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

BNP and Vascular Surgery

Clinicaltrials.gov identifier NCT03926104

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted April 24, 2019

Study Description

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.

  • Condition or Disease:Mets
    General Anesthesia
    Postoperative Period
    Vascular Surgery
    Abdominal Aortic Aneurysm
    Natriuretic Peptide, Brain
    Preoperative Period
  • Intervention/Treatment:
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Estimated Enrollment: 165 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Evaluation of BNP Values in Major Vascular Surgery
  • Actual Study Start Date: December 2018
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of cardiac events [ Time Frame: from the induction of general anesthesia until hospital discharge, an average of 1 week ]
  • Secondary Outcome Measures: 1. Incidence of postoperative pulmonary complication [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
  • 2. Incidence of postoperative neurological complication [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
  • 3. Incidence of postoperative acute kidney failure [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
  • 4. Incidence of unplanned ICU admission [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
  • 5. Hospital length of stay [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
  • 6. Incidence of mortality [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: Adult undergoing major vascular surgery
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

Contacts and Locations
Contacts

Contact: Elena Giovanna Bignami, MD Professor elenagiovanna.bignami@unipr.it

Locations

Italy
Elena Giovanna Bignami
Parma

Sponsors and Collaborators

University of Parma

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