An observational study in Non Cardiac Surgery, sponsored by University Hospital Heidelberg. Status unknown at 1 site in Germany. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2018-09-25.
Sponsored by University Hospital Heidelberg · Observational
Multicentre international prospective cohort study designed to evaluate whether preoperative presepsin (sCD14-ST) is associated with the composite endpoint: all-cause mortality and major adverse cardiovascular or cerebrovascular events (MACCE) after elevated risk non-cardiac surgery. If so:
Major non-cardiac surgery is still associated with relevant cardiovascular mortality and morbidity. In Europe, in-hospital mortality exceeded 7% in patients with coronary artery disease and in those with congestive heart failure. Within 30 days of non-cardiac surgery procedures, 8% of patients will suffer a major cardiovascular event.
Immunological processes, increased recruitment and infiltration of innate and adaptive immune cells into atherosclerotic lesions, have been shown to drive perioperative atherosclerotic lesion progression and plaque destabilization and are thought to promote plaque rupture. When classical monocytes are activated to inflammatory non-classical monocytes, the membrane-bound cell surface protein CD14 is released into circulation. In plasma, soluble CD14 (sCD14) is cleaved by lysosomal proteases. The N-terminal 13kDa fragment constitutes sCD14 subtype (sCD14-ST), also called presepsin. Presepsin has been established as a marker for early identification of patients with systemic infections. Recently, presepsin has been proposed as a biomarker for preoperative risk prediction in cardiac surgery. Our preliminary results in a limited number of patients suggest that presepsin is associated with major adverse cardiovascular and cerebrovascular events after non-cardiac surgery as well with all-cause mortality. Presepsin might have a test characteristic superior to conventional risk assessment on the basis of the revised cardiac risk index (RCRI), high-sensitivity cardiac Troponin-T (hs-cTnT) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP).
Preoperative presepsin quantification might help to identify non-cardiac surgery patients prone to experience perioperative major adverse cardiovascular and cerebrovascular events.
patients undergoing elective, elevated-risk noncardiac surgery.
Inclusion criteria:
No exclusion criteria
I
Composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke
Number of Patients with Composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke
Time frame: at discharge or at day 30 after surgery (whatever comes first)
Composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke
Number of Patients with composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke for patients recruited in centers conducting 30-day follow-up
Time frame: 30 days
All-cause mortality
Number of patients that die of any cause
Time frame: 30 days
Non-fatal cardiac arrest
Number of patients with non-fatal cardiac arrest
Time frame: 30 days
Myocardial infarction
Number of patients with myocardial infarction
Time frame: 30 days
Congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care (≥24h)
Number of patients with congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care (≥24h)
Time frame: 30 days
Stroke
Number of patients with stroke
Time frame: 30 days
Cardiovascular mortality
Number of patients that die of a cardiovascular cause
Time frame: 30 days
In-hospital cardiovascular mortality
Number of patients that die in hospital of a cardiovascular cause
Time frame: 30 days
Complications ≥ 3 in Clavien Dindo Classification
Number of patients with ≥ 3 complications in Clavien Dindo Classification
Time frame: within 30 days after surgery
Length of Hospital stay
Number of days participants stayed in hospital
Time frame: within 30 days after surgery
Length of ICU stay
Number of days participants stayed in ICU
Time frame: within 30 days after surgery
Myocardial injury after non-cardiac surgery (MINS)
Number of Patients with MINS
Time frame: within 30 days after surgery
Plan to share: Undecided
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University Hospital Heidelberg