Predictive Value of suPAR and hsCRP on Postoperative Mortality in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate whether preoperative soluble urokinase plasminogen activating receptor (suPAR) and High-sensitivity C-Reactive Protein (hsCRP) are independent markers of death after cardiac surgery. Further, to assess whether suPAR and hsCRP provides increased predictive accuracy of the clinical risk model EuroSCORE II. The purpose of the study is to gain knowledge on whether these inflammatory biomarkers might be able to reveal a pro-inflammatory disease state that represents a significant risk in patients undergoing cardiovascular surgery. Hence, these biomarkers may assist clinicians in selecting compassionate treatment for high risk patients.

Official Title
-----------------
Predictive Value of suPAR and hsCRP on Postoperative Mortality in 951 Patients Undergoing Elective On-pump Cardiac Surgery

Conditions
-----------------
Thoracic Surgery, Cardiac Surgical Procedures, Biomarkers

Intervention / Treatment
-----------------
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned elective on-pump cardiac surgery (isolated coronary artery bypass graft (CABG), single and multiple valvular procedures, combined CABG and valvular surgery, and others) Given informed consent on delivering a blood sample for the biobank. Exclusion Criteria: Peroperatively cancelling the surgery Sudden change to off-pump coronary artery bypass (OPCAB) surgery Death prior to surgery Project blood samples not available.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elective on-pump cardiac surgery patients<br>Adult patients (≥18 years) undergoing elective on-pump cardiac surgery (isolated coronary artery bypass graft (CABG), single and multiple valvular procedures, combined CABG and valvular surgery, and others). | Other: Blood sampling<br>* Analysis will be performed using commercially available analyses (suPARnostic® kit (validated to measure suPAR concentrations between 0.6 and 22 ng/mL) (ViroGates)). HsCRP will be measured by high sensitivity CRP assays (Tina-quant hs-CRP latex assay (validated to measure CRP concentrations between 0.3 - 20 mg/L) (Roche/Hitachi)). In patients with CRP>20 mg/L a regular CRP-measurement will be performed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of preoperative suPAR values in relation to the censored time-to-event outcome death from any cause |  | from index surgery to censoring date 12.31.2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of preoperative hsCRP values in relation to the censored time-to-event outcome death from any cause |  | from index surgery to censoring date 12.31.2018 | 
| Assess whether adding suPAR, hsCRP or combined suPAR+hsCRP measurements improves predictive accuracy of EuroSCORE II |  | from index surgery to 30 days postoperative | 
| Sensitivity of the models; EuroSCORE II, suPAR, hsCRP, suPAR+hsCRP, EuroSCOREII+suPAR, EuroSCOREII+hsCRP and EuroSCOREII+suPAR+hsCRP in relation to the time-to-event outcome death from any cause |  | from index surgery to 30 days postoperative | 
| Specificity of the models; EuroSCORE II, suPAR, hsCRP, suPAR+hsCRP, EuroSCOREII+suPAR, EuroSCOREII+hsCRP and EuroSCOREII+suPAR+hsCRP in relation to the time-to-event outcome death from any cause |  | from index surgery to 30 days postoperative |