Clinical trial NCT03489486: Presepsin (sCD14-ST) for Prediction of Perioperative Risk - MET-REPAIR Nested Cohort Study
Official title: MET: REevaluation for Perioperative cArdIac Risk (MET-REPAIR): a Prospective, Multi-centre Cohort Observational Study- Presepsin (sCD14-ST) for Perioperative Risk Prediction Nested Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Cardiac Surgery
Keywords: Presepsin
sCD14-ST
biomarker
perioperative risk
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: European Society of Anaesthesiology
First posted: 2018-04-05
Enrollment: 1695
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing elective, elevated-risk noncardiac surgery.

Brief summary: 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:

1. What is the optimal cut-off for presepsin to predict the composite endpoint all-cause mortality and MACCE?
2. Does the calculated optimal cut-off improve prediction of the composite endpoint all-cause mortality and MACCE when added to clinical data and established biomarkers?

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* Enrollment in MET-REPAIR (NCT03016936)
* Signed written informed consent

No exclusion criteria

I

Primary outcomes:
measure: 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
timeFrame: at discharge or at day 30 after surgery (whatever comes first)
Secondary outcomes:
measure: 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
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 30 days
measure: Non-fatal cardiac arrest
timeFrame: 30 days
measure: Myocardial infarction
timeFrame: 30 days
measure: Congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care (≥24h)
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
measure: Cardiovascular mortality
timeFrame: 30 days
measure: In-hospital cardiovascular mortality
timeFrame: 30 days
measure: Complications ≥ 3 in Clavien Dindo Classification
timeFrame: within 30 days after surgery
measure: Length of Hospital stay
timeFrame: within 30 days after surgery
measure: Length of ICU stay
timeFrame: within 30 days after surgery
measure: Myocardial injury after non-cardiac surgery (MINS)
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Anaesthesiology, University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Department of Anesthesiology, Univeristy Hospital Heidelberg
name: Jan Larmann, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
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