Biomarkers, Blood Pressure, BIS: Risk Stratification/Management of Patients at Cardiac Risk in Major Noncardiac Surgery "BBB"


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria (both A and B fulfilled):
- A) undergoing major noncardiac surgery, defined as:
- vascular surgery (with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies)
- intraperitoneal surgery
- intrathoracic surgery
- major orthopedic surgery
- B) at cardiovascular risk, defined as meeting at least 1 of the following 6 criteria:
- history of coronary artery disease
- history of peripheral vascular disease
- history of stroke
- hospitalization for congestive heart failure
- undergoing major vascular surgery, with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies
- fulfillment of any 3 of the 7 Lee criteria, defined as:
- undergoing intrathoracic or intraperitoneal surgery
- anamnestic transient ischemic attack (TIA)
- any history of CHF or history of pulmonary edema
- diabetes
- serum creatinine > 175 mcmol/l
- age > 70 years
- undergoing emergent or urgent surgery

Exclusion Criteria

- General
- pregnancy
- inclusion in another clinical trial with any endpoints in common with the BBB Study: hs-cTnI, components of MACE (acute coronary syndrome [ACS], congestive heart failure [CHF], coronary revascularization, stroke, acute kidney injury [AKI], new chronic kidney disease [CKD] or progression of CKD, mortality)
- previously enrolled in BBB Study
- emergent surgery
- presence of any active cardiac conditions:
- unstable coronary syndromes: unstable or severe (CCS III or IV) angina
- decompensated heart failure: NYHA IV, worsening or new-onset
- significant arrhythmias: high-grade AV-block (Mobitz II and third-degree), symptomatic bradycardia, symptomatic ventricular arrhythmias, supraventricular arrhythmias with uncontrolled ventricular rate (>100bpm at rest), newly recognized ventricular tachycardia
- severe valvular disease: severe aortic stenosis (mean pressure gradient > 40 mmHg, aortic valve area < 1.0 cm2, symptomatic), symptomatic mitral stenosis (progressive dyspnea on exertion, externional presyncope, heart failure)
- any transplantation