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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

Tracking Information
First Submitted Date January 7, 2019
First Posted Date April 24, 2019
Last Update Posted Date April 24, 2019
Actual Study Start Date December 10, 2018
Estimated Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2019)
Incidence of cardiac events [ Time Frame: from the induction of general anesthesia until hospital discharge, an average of 1 week ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 23, 2019)
  • Incidence of postoperative pulmonary complication [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
  • Incidence of postoperative neurological complication [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
  • Incidence of postoperative acute kidney failure [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
  • Incidence of unplanned ICU admission [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
  • Hospital length of stay [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
  • Incidence of mortality [ Time Frame: from immediately after surgery until hospital discharge, an average of 1 week ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BNP and Vascular Surgery
Official Title Evaluation of BNP Values in Major Vascular Surgery
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult undergoing major vascular surgery
Condition
  • General Anesthesia
  • Vascular Surgery
  • Abdominal Aortic Aneurysm
  • Natriuretic Peptide, Brain
  • Mets
  • Preoperative Period
  • Postoperative Period
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2019)
165
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 10, 2020
Estimated Primary Completion Date December 10, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Elena Giovanna Bignami, MD Professor elenagiovanna.bignami@unipr.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03926104
Other Study ID Numbers 39751 del 19/10/2018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Elena Giovanna Bignami, University of Parma
Study Sponsor University of Parma
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Parma
Verification Date April 2019