CClinicalTrials.gg
CompletedNCT02570607BNPUpdated Jul 24, 2018

Preoperative BNP as Biomarker of Postoperative Cardiovascular Complications

An observational study in Postoperative Cardiovascular Complications, sponsored by Centre Hospitalier Universitaire de Nice. Completed. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-07-24.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 100 Years
Sex
All
01

Study 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 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.

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.

02

Conditions studied

  • Postoperative Cardiovascular Complications
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patient Who have to undergoing moderate or high cardiovascular risk non-ambulatory scheduled surgery with the exception of cardiac surgery

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Interventions

  • BiologicalBNP dosage
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02570607
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Oct 7, 2015
Start date
Nov 2015
Primary completion
May 2016
Completion
May 2017
Last update
Jul 24, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion