Evaluation of BIomarkers for POstoperative Complications in Non-cardiac Surgery Patients

Study Overview
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Brief Summary
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Aim of this study is to evaluate whether IPF, hsTnT and NT pro-BNP can be used as biomarkers for perioperative risk stratification predicting postoperative complications in patients undergoing elective non-cardiac surgery.

Detailed Description
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Immature platelets (IPF), high sensitive Troponin T (hsTnT) and NTpro-BNP are associated with major adverse cardiovascular events (MACE), myocardial injury after noncardiac surgery (MINS) and mortality. This study is designed to investigate whether the biomarkers IPF, hsTnT and NTpro-BNP can predict postoperative complications assessed by the Clavien-Dindo classification. Patients are screened for participation in the SUPERADD study (NCT03167656) and who gave written informed consent are included in this study. The biomarkers are analysed before induction of anaesthesia and at the PACU (postoperative anaesthesia care unit) next to other labaratory parameters. Further during preanaesthesia visit all relevant comorbidities. the ASA (American Society of Anesthesiology)-Status, the POSPOM (Preoperative Score to Predict Postoperative Mortality) and the CCI (Charlson Comobidity Index) are obtained. Intraoperative parameters like blood pressure, heart rate, estimated blood loss are measured and complications in the PACU are recorded. Primary Endpoint are postoperative complications assessed with the Cavien-Dindo classification ≥ 2. For each biomarker three ROC curves (preoperative value, postoperative value and the difference between pre- to postoperative value) are obtained and the respective AUC determined. The association of each biomarker and the combination of the biomarkers are tested using regession analyses.

Official Title
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Evaluation of IPF, hsTnT and Pro-BNP as Biomarkers for Perioperative Risk Stratification Among Patients Undergoing Elective Non-cardiac Surgery

Conditions
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Perioperative/Postoperative Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consense Age > 18 years ASA Score 3 or 4 elective non-cardiac high risk surgery Exclusion Criteria: emergency surgery need for dialysis liver cirrhosis child C intolerance of albumin participation in other AMG (medicines law) study pregnancy or breastfeeding patients with attendants concerning medical matters ASA V patients patients with BMI > 35 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications determined with the calvien-dindo classification | Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. Each domain is graded between grade I and V (death of a patient). | date of surgery until hospital discharge (approx. 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital mortality | Rate of Mortality among study patients | date of surgery until hospital discharge (approx. 30 days) | 
| 6 months mortalitiy | Rate of Mortality among study patients | date of surgery until 6 months after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative outcome, clavien-dindo classification, IPF, hsTnT, proBNP