Biomarkers in Perioperative Management

Study Overview
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Brief Summary
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Rationale: The rate of postoperative complications after high-risk surgery remains high despite recent advances in perioperative management. There is a lack of objective and reliable information that can be used for risk stratification and to guide treatment decisions. Objective: To describe the perioperative biomarker response in surgical patients with and without a postoperative complication and construct a preoperative and postoperative prediction model for postoperative complications. To systematically collect perioperative blood samples and clinical data in high-risk surgical patients for the development en analysis of biomarkers. Study design: Multicenter, prospective, observational study. Study population: 4819 patients undergoing elective cardiac, colorectal, vascular and lung surgery. Intervention (if applicable): Not applicable. Main study parameters/endpoints: Main study parameters are levels of PCT, CRPhs, IL-6, GDF-15, sFLT, NT-proBNP, cTNThs, CysC and NGAL. Main study endpoint is the occurrence of a major postoperative complication which is defined as a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death within 30 days of surgery. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In each patient five blood samples will be drawn for analysis. Most of the blood samples are drawn simultaneously with routine perioperative laboratory testing, which is common in this study population. In case a patient is admitted to the Intensive Care Unit blood samples will be collected using an arterial line. There are no direct risks or benefits for patients included in the study.

Official Title
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Biomarkers to Guide Perioperative Management and Improve Outcome in High-risk Surgery

Conditions
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Postoperative Complications, Quality of Life, Death

Intervention / Treatment
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* Diagnostic Test: Biomarker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiac surgery (isolated coronary artery bypass grafting or combined with single valve surgery, isolated single valve surgery) Gastrointestinal surgery (colorectal, pancreatic, gastric surgery). Vascular surgery (open and endovascular aortic surgery, peripheral vascular surgery) Lung surgery (pneumonectomy,(bi)(sleeve)lobectomy or segmentectomy) Exclusion Criteria: Age < 18 years Pregnancy Emergent surgery No informed consent

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Biomarker|Perioperative biomarker analyses|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication | a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure to rescue | In-hospital death following a major complication | 30 days | 
| Mortality | Death | 120 days | 
| DAH120 | Days alive and out of hospital | 120 days | 
| Disability | Change in disability according to WHODAS 2.0 - 12 item | 120 days |