Postoperative Cardiovascular ComplicationsBNPNCT02570607
Preoperative BNP as Biomarker of Postoperative Cardiovascular Complications
An observational study of Postoperative Cardiovascular Complications, run by Centre Hospitalier Universitaire de Nice.
Trial summary
BNP is a hormone that predicts preoperatively the occurrence of postoperative cardiovascular complications. In practice, the problem is that the practitioner don't know the most opportune moment for the preoperative sample or what threshold used to classify our patient in patients at risk of cardiovascular… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Cardiovascular Complications
- What is being tested?
- BNP dosage
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to May 2017
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient Who have to undergoing moderate or high cardiovascular risk non-ambulatory scheduled surgery with the exception of cardiac surgery
Who may be able to join
- Major patients who was not opposed to one additional sample
- Who have to undergoing moderate or high cardiovascular risk non-ambulatory scheduled surgery with the exception of cardiac surgery
- With predictable delay between the preoperative evaluation and the surgery > 15 days
Who cannot join
- Moderate cardiovascular risk surgeries (1-5%):
- Carotid Endarterectomy
- Surgery of the Head and Neck
- Thoracic surgery and intraperitoneal (thromboembolism)
- Orthopaedic surgery (thromboembolism)
- Prostate Surgery (thromboembolism)
Show all 10Show fewer
- High cardiovascular risk surgeries (> 5%):
- Aortic surgery with risk of sudden changes in blood pressure during clamping (acute pulmonary edema, ischemia)
- declamping (coronary perfusion)
- other major vascular surgery - peripheral vascular surgery - long surgery with significant blood loss or fluid and electrolyte
About this study
Official title: Relevance of Preoperative BNP as a Biomarker of Postoperative Cardiovascular Complications in Major Non-cardiac Adult Surgery
BNP is a hormone that predicts preoperatively the occurrence of postoperative cardiovascular complications. In practice, the problem is that the practitioner don't know the most opportune moment for the preoperative sample or what threshold used to classify our patient in patients at risk of cardiovascular complication or not at risk.
The purpose of this study is to determine the best time to dose the preoperative BNP with a specific threshold being associated with it allowing the practitioner to assess more accurately the post operative cardiovascular risk patients and possibly offer them strategies taking different load.
Read more
The BNP will be dosed during the anesthetic consultation and the day of surgery in immediate preoperative operating room. Post-operative cardiovascular complications will be collected during hospitalization of the patient and by telephone contact on the 28th day, 90th day and 6th postoperative months.
The investigator then establish the threshold BNP most informative for both sampling times and then compare them to determine the most discriminating dosage and thus the most appropriate time for the determination of BNP.
Read the detailed description
The morbidity and mortality of non-cardiac major surgery is mainly due to cardiovascular complications. BNP is a hormone for predicting preoperatively the occurrence of these complications. Widely used in cardiac surgery, it is not routinely used in non-cardiac major surgery. His interest in this type of surgery has yet been proven by numerous studies.
In practice, the problem with this biomarker is the pratitioner do not know the most opportune moment for the preoperative dose or what threshold used to classify our patient patients at risk of cardiovascular complication or not at risk.
Indeed, recent literature reviews are used to highlight the fact that existing studies on the subject using each method or BNP assay devices and heterogeneous preoperative dosing of different times or even BNP not exactly specified. It thus appears as many different levels of BNP. Practitioners did not then know when dosing the BNP and what threshold is based.
The purpose of this study is to determine the best time to dose the preoperative BNP with a specific threshold being associated with it allowing the practitioner to assess more accurately the post operative cardiovascular risk patients and possibly offer them strategies taking different load.
The BNP will be dosed during the anesthetic consultation and the day of surgery in immediate preoperative operating room. Post-operative cardiovascular complications will be collected during hospitalization of the patient and by telephone contact on the 28th day, 90th day and 6th postoperative months.
The investigator then establish the threshold BNP most informative for both sampling times and then compare them to determine the most discriminating dosage and thus the most appropriate time for the determination of BNP.
There will be no immediate benefit to the patient but our study will help in the future, to adapt the management of perioperative patients depending on the value of pre immediate operative BNP to reduce postoperative complications.
- Being tested
- BNP dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNP dosageBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of a complication or cardiovascular events
The endpoint is the occurrence of a complication or cardiovascular events (composite endpoint). A cardiovascular event is defined by the occurrence of syndromes such as IDM, acute cardiogenic lung edema, a rhythm disturbance (ACFA, flutter, TV, FV) or c
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cardiovascular ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570607
- Sponsor's protocol ID
- 15-PP-10
- Acronym
- BNP
- Status last verified
- Jul 2018
- First submitted
- 5 Oct 2015
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Preoperative BNP as a Biomarker of Postoperative Cardiovascular Complications in Major Non-cardiac Adult Surgery
- ClinicalTrials.gov ID
- NCT02570607
- Acronym / sponsor ID
- BNP / 15-PP-10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 7 Oct 2015 (estimated)
- 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.
BNP is a hormone that predicts preoperatively the occurrence of postoperative cardiovascular complications. In practice, the problem is that the practitioner don't know the most opportune moment for the preoperative sample or what threshold used to classify our patient in patients at risk of cardiovascular complication or not at risk.
The purpose of this study is to determine the best time to dose the preoperative BNP with a specific threshold being associated with it allowing the practitioner to assess more accurately the post operative cardiovascular risk patients and possibly offer them strategies taking different load.
The BNP will be dosed during the anesthetic consultation and the day of surgery in immediate preoperative operating room. Post-operative cardiovascular complications will be collected during hospitalization of the patient and by telephone contact on the 28th day, 90th day and 6th postoperative months.
The investigator then establish the threshold BNP most informative for both sampling times and then compare them to determine the most discriminating dosage and thus the most appropriate time for the determination of BNP.
Detailed description
The morbidity and mortality of non-cardiac major surgery is mainly due to cardiovascular complications. BNP is a hormone for predicting preoperatively the occurrence of these complications. Widely used in cardiac surgery, it is not routinely used in non-cardiac major surgery. His interest in this type of surgery has yet been proven by numerous studies.
In practice, the problem with this biomarker is the pratitioner do not know the most opportune moment for the preoperative dose or what threshold used to classify our patient patients at risk of cardiovascular complication or not at risk.
Indeed, recent literature reviews are used to highlight the fact that existing studies on the subject using each method or BNP assay devices and heterogeneous preoperative dosing of different times or even BNP not exactly specified. It thus appears as many different levels of BNP. Practitioners did not then know when dosing the BNP and what threshold is based.
The purpose of this study is to determine the best time to dose the preoperative BNP with a specific threshold being associated with it allowing the practitioner to assess more accurately the post operative cardiovascular risk patients and possibly offer them strategies taking different load.
The BNP will be dosed during the anesthetic consultation and the day of surgery in immediate preoperative operating room. Post-operative cardiovascular complications will be collected during hospitalization of the patient and by telephone contact on the 28th day, 90th day and 6th postoperative months.
The investigator then establish the threshold BNP most informative for both sampling times and then compare them to determine the most discriminating dosage and thus the most appropriate time for the determination of BNP.
There will be no immediate benefit to the patient but our study will help in the future, to adapt the management of perioperative patients depending on the value of pre immediate operative BNP to reduce postoperative complications.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient Who have to undergoing moderate or high cardiovascular risk non-ambulatory scheduled surgery with the exception of cardiac surgery
Key inclusion criteria (3 listed)
- Major patients who was not opposed to one additional sample
Key exclusion criteria (10 listed)
- Moderate cardiovascular risk surgeries (1-5%):
- Carotid Endarterectomy
- Surgery of the Head and Neck
- Thoracic surgery and intraperitoneal (thromboembolism)
- Orthopaedic surgery (thromboembolism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNP dosage | Biological | – |
Primary outcome
occurrence of a complication or cardiovascular events
Time frame: 2 years
The endpoint is the occurrence of a complication or cardiovascular events (composite endpoint). A cardiovascular event is defined by the occurrence of syndromes such as IDM, acute cardiogenic lung edema, a rhythm disturbance (ACFA, flutter, TV, FV) or c
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
Related trials for Postoperative Cardiovascular Complications
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cardiovascular Complications, run by Centre Hospitalier Universitaire de Nice.
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 10 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: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of a complication or cardiovascular events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2018.