Perioperative myocardial injury
Conditions
Interventions
Group 1: The study includes patients aged = 45 years who undergo elective, non-cardiac high-risk surgery with planned postoperative admission on intensive care unit. This includes, in particular, comp
Sponsors
Universitätsmedizin Halle (Saale) - Universitätsklinik für Anästhesiologie und Operative Intensivmedizin
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: Ability to give consent, planned post-operative admission to the anaesthesiology intensive care unit following elective, non-cardiac surgical procedures involving a high procedural risk
Exclusion criteria
Exclusion criteria: Cardiac surgery, emergency and urgent surgery (N0–N2), patients unable to give consent, age < 45 years, refusal to participate in the study, pregnancy, previous surgery within the last 2 weeks, acute infectious disease (gastroenteritis, cholecystitis, appendicitis, peritonitis, pneumonia, etc.) within the previous 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the incidence of cardiovascular complications. This is defined as a composite of (1) perioperative myocardial injury or (2) cardiovascular death within 30 days. Perioperative myocardial injury is defined as an increase in hs-Troponin T of more than the 99th percentile of the upper reference limit, i.e. an increase in hs-Troponin T of more than 14 ng/L. Pre- and postoperative hs-Troponin T measurements are compared (measurement timepoints: preoperatively, immediately postoperatively, on the first and second postoperative days). If hs-Troponin T is already elevated preoperatively, a further increase in hs-Troponin T of at least 25% (but at least 14 ng/L) from the baseline value is classified as perioperative myocardial injury if the change in Troponin is not attributable to a non-ischaemic cause such as acute kidney injury, pulmonary embolism or sepsis. Vascular death includes perioperative deaths (within 30 days post-operatively) following a myocardial infarction, cardiac arrest, stroke, cardiac revascularisation, pulmonary embolism or deaths of unknown cause. This is recorded by reviewing hospital records and through a telephone interview after 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Cardiovascular events during hospitalisation - Complications in the intensive care unit (e.g. sepsis, cardiogenic shock, acute kidney failure, ARDS) - Duration of circulatory support with catecholamines - Time to extubation - Length of stay in the intensive care unit - Length of hospital stay - Mortality during hospitalisation - Cardiovascular events and mortality at 1, 6 and 12 months | — |
Countries
Germany
Contacts
Public ContactSascha Till Stefan Rittig
Universitätsmedizin Halle - Universitätsklinik für Anästhesiologie und Operative Intensivmedizin
Outcome results
None listed