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 |
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General Anesthesia Vascular Surgery Abdominal Aortic Aneurysm Natriuretic Peptide, Brain Mets Preoperative Period Postoperative Period |
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:
The data will be transferred on Excel worksheet, utilized for descriptive analysis related at every variable.
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 |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elena Giovanna Bignami, MD Professor | elenagiovanna.bignami@unipr.it |
Italy | |
Elena Giovanna Bignami | Recruiting |
Parma, Italy, 43126 | |
Contact: Elena Giovanna Bignami, MD Professor |
Tracking Information | |||||
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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 |
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 |
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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. |
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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:
The data will be transferred on Excel worksheet, utilized for descriptive analysis related at every variable. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Adult undergoing major vascular surgery | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
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 |
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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 |