General AnesthesiaBNPinVascNCT03926104
BNP and Vascular Surgery
An observational study of General Anesthesia and Vascular Surgery, run by University of Parma at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia, Vascular Surgery, Abdominal Aortic Aneurysm
- How many people
- 165 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2018to 10 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult undergoing major vascular surgery
Who may be able to join
- Ability to provide an informed consent
- Age >18 years old
- Elective abdominal aortic aneurysm surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Elena Giovanna Bignami, MD Professor contact
Italy1 site, 1 recruiting
- Recruiting
Elena Giovanna Bignami
Parma, 43126
Elena Giovanna Bignami, MD Professor
About this study
Official title: Evaluation of BNP Values in Major Vascular Surgery
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.
Read more
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.
Read the 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.
- Conditions
- General Anesthesia, Vascular Surgery, Abdominal Aortic Aneurysm, Natriuretic Peptide, Brain, Mets, Preoperative Period
- Medical subject headings
- Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiac events
Measured: from the induction of general anesthesia until hospital discharge, an average of 1 week
Secondary outcomes (6)
Incidence of postoperative pulmonary complication
Measured: from immediately after surgery until hospital discharge, an average of 1 week
Incidence of postoperative neurological complication
Measured: from immediately after surgery until hospital discharge, an average of 1 week
Incidence of postoperative acute kidney failure
Measured: from immediately after surgery until hospital discharge, an average of 1 week
Incidence of unplanned ICU admission
Measured: from immediately after surgery until hospital discharge, an average of 1 week
Hospital length of stay
Measured: from immediately after surgery until hospital discharge, an average of 1 week
Incidence of mortality
Measured: from immediately after surgery until hospital discharge, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start10 Dec 2018
- Primary completion10 Dec 2020 (estimated)
- Study completion10 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Giovanna Bignami, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926104
- Sponsor's protocol ID
- 39751 del 19/10/2018
- Acronym
- BNPinVasc
- Status last verified
- Apr 2019
- First submitted
- 7 Jan 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29332544Wayne 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.
PubMed 26073822Biccard 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.
PubMed 24738805Bryce 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.
PubMed 23058722Vetrugno 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.
PubMed 22387082
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of BNP Values in Major Vascular Surgery
- ClinicalTrials.gov ID
- NCT03926104
- Acronym / sponsor ID
- BNPinVasc / 39751 del 19/10/2018
- Conditions
- General Anesthesia, Vascular Surgery, Abdominal Aortic Aneurysm, Natriuretic Peptide, Brain, Mets, Preoperative Period
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 10 Dec 2020 (estimated)
- Study completion
- 10 Dec 2020 (estimated)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult undergoing major vascular surgery
Key inclusion criteria (3 listed)
- Ability to provide an informed consent
- Age >18 years old
- Elective abdominal aortic aneurysm surgery
Key exclusion criteria (6 listed)
- Emergency surgery
- Age ˂ 18 years old
- Creatinine >2mg/dl
- Diseases of ascending aorta, aortic arch or thoracic aorta
- Chronic atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of cardiac events
Time frame: from the induction of general anesthesia until hospital discharge, an average of 1 week
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Background: PubMed 29332544Vetrugno 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.
- Background: PubMed 26073822Wayne 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.
- Background: PubMed 24738805Biccard 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.
- Background: PubMed 23058722Bryce 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.
- Background: PubMed 22387082Vetrugno 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.
Related trials for General Anesthesia
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Giovanna Bignami, MD Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Vascular Surgery, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Giovanna Bignami, MD Professor (elenagiovanna.bignami@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiac events (time frame: from the induction of general anesthesia until hospital discharge, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03926104, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.