BNP Evaluation Before Surgery Study: an Observational Study of Natriuretic Peptide Levels Prior to Surgery.

Study Overview
=================
Brief Summary
-----------------
A prospective, multi-centre, observational study of preoperative natriuretic peptide testing for patients undergoing non-cardiac surgery conducted over four weeks.

Detailed Description
-----------------
Identification of high-risk surgical patients requires risk stratification. Current clinical risk stratification tools, e.g. Revised Cardiac Risk Index (RCRI), only have a moderate ability to identify these patients. International guidelines, like Canadian Cardiovascular Society on perioperative cardiovascular risk assessment, advocate that all patients 45 yrs and older or patients >18y rs who have significant cardiovascular disease and who are coming for intermediate to high-risk surgery, should get natriuretic peptide (NP) testing. This is because raised preoperative B-type natriuretic peptides have a strong association with postoperative cardiac complications according to observational studies and meta-analyses. However, in these patients with significant cardiovascular disease coming for intermediate to high-risk surgery it is unknown how many patients will actually have raised B-type natriuretic peptides. That is, which group of patients have an even higher risk in this already high-risk group. Natriuretic peptide (NP) testing is also expensive. Further identification of patients that need NP testing will reduce costs and focus efforts on those patients who really need it.

Official Title
-----------------
Evaluating Perioperative Interventions to Improve Patient outComes (EPIC-2): BNP Evaluation Before Surgery Study

Conditions
-----------------
Surgery, Cardiovascular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 45 years of age. Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital. With at least one of the following criteria: History of ischaemic heart disease or peripheral vascular disease (coronary equivalent) History of stroke or transient ischaemic attack History of congestive cardiac failure Diabetes currently on an oral hypoglycaemic agent or insulin Serum creatinine >175 µmol/L (>2.0mg/dl) Exclusion Criteria: Patient refusal to participate. Patients presenting for cardiac and obstetric or emergency surgery.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High-risk elective surgical patients<br>The patient population to be studied are elective patients for non-cardiac surgery. Age ≥ 45 years of age. Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital. With at least one of the following criteria: History of ischaemic heart disease or peripheral vascular disease (coronary equivalent) History of stroke or transient ischaemic attack History of congestive cardiac failure Diabetes currently on an oral hypoglycaemic agent or insulin Serum creatinine >175 µmol/L (>2.0mg/dl) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raised natriuretic peptide | Determine the prevalence of abnormal (raised) NP in patients with clinical risk criteria. | preoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk prediction | The secondary objective is to develop a risk prediction model for those patients who will need preoperative NP screening. | preoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High risk surgical patients, Risk stratification, Natriuretic peptide testing