Preoperative BNP as Biomarker of Postoperative Cardiovascular Complications

NCT02570607 | Completed

• 1 other identifier: 15-PP-10
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Cardiovascular Complications

Outcome Measures

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

  2 years

Interventions

BNP dosage BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 7, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07