Predictive Value of suPAR and hsCRP on Postoperative Mortality in Cardiac Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Elective on-pump cardiac surgery patients 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
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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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]
Other Outcome Measures
- 30 days mortality measured by a yes/no question of "all-cause mortality" [from index surgery to 30 days]
- 1-year mortality measured by a yes/no question of "all-cause mortality" [from index surgery to 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Planned elective on-pump cardiac surgery (isolated coronary artery bypass graft (CABG), single and multiple valvular procedures, combined CABG and valvular surgery, and others)
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Given informed consent on delivering a blood sample for the biobank.
Exclusion Criteria:
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Peroperatively cancelling the surgery
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Sudden change to off-pump coronary artery bypass (OPCAB) surgery
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Death prior to surgery
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Project blood samples not available.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiothoracic Anaesthesiology, Rigshospitalet | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
- Persimune
- University of Copenhagen
Investigators
- Principal Investigator: Sebastian R Rasmussen, MD, Rigshospitalet, Denmark
Study Documents (Full-Text)
More Information
Publications
None provided.- H-18002379