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:
Participant gender:
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.