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BNP and Vascular Surgery (BNPinVasc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926104
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Elena Giovanna Bignami, 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.


Condition or disease
General Anesthesia Vascular Surgery Abdominal Aortic Aneurysm Natriuretic Peptide, Brain Mets Preoperative Period Postoperative Period

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.

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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 10, 2018
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine





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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926104


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

Locations
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Italy
Elena Giovanna Bignami Recruiting
Parma, Italy, 43126
Contact: Elena Giovanna Bignami, MD Professor         
Sponsors and Collaborators
University of Parma
Publications:
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Responsible Party: Elena Giovanna Bignami, Clinical Professor, University of Parma
ClinicalTrials.gov Identifier: NCT03926104    
Other Study ID Numbers: 39751 del 19/10/2018
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases