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

• Status: Completed
• Trial end date: 2020-04-17
• Target enrollment: 0
• Participant gender: All

Summary

Major adverse cardiovascular events (MACE) are a leading cause of serious complications and death following major noncardiac surgery. The heart biomarkers brain-type natriuretic peptide (BNP) and high-sensitivity troponin I/T (hs-TnI/T), may aid in estimating the risk of surgery

• low values may permit identifying patients at a very low risk of postoperative complications, potentially helping to avoid unnecessary tests and delays prior to surgery.

Recent studies suggest that the manner in which an anesthetic is conducted may have an important impact on postoperative outcomes. The combination of low blood pressure (BP) and a deep level of anesthesia despite a low dose of anesthetic - also known as a "triple low" - has been linked to increased complications and death following surgery. However, it is unclear whether triple lows actually cause postoperative complications or whether they are merely an indicator of a sick patient, who is in general more likely to suffer from cardiovascular events in the near future. To answer this question, in this study patients will be randomly assigned to groups with lower and higher blood pressures, and the postoperative rates of major adverse cardiovascular events and of relevant increases in hs-TnI (a marker of cardiac injury) compared.

Another important question is that of the optimal blood pressure target during surgery. Currently there are no established methods of tailoring blood pressure management to the individual patient. In the study the investigators will perform ambulatory 24h BP measurements prior to surgery to measure the patients' average BP during sleep. In the analysis of the study data, the investigators will try to determine the relationship of preoperative biomarker levels, intraoperative BP (both in relation to fixed targets and to the patient's own night-time BP) and of anesthetic depth with the occurrence of major adverse cardiovascular events after surgery.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Miodrag Filipovic, Prof. Dr. med.

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

• RCT

• 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