Clinical trial NCT04292249: Predictive Value of suPAR and hsCRP on Postoperative Mortality in Cardiac Surgery
Official title: Predictive Value of suPAR and hsCRP on Postoperative Mortality in 951 Patients Undergoing Elective On-pump Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Cardiac Surgical Procedures
Biomarkers
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Persimune
name: University of Copenhagen
First posted: 2020-03-03
Enrollment: 951
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥18 years) undergoing cardiac surgery at department of Cardiothoracic Surgery at Rigshospitalet, Copenhagen University Hospital, Denmark

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.


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.

Primary outcomes:
measure: Association of preoperative suPAR values in relation to the censored time-to-event outcome "death from any cause"
timeFrame: from index surgery to censoring date 12.31.2018
Secondary outcomes:
measure: Association of preoperative hsCRP values in relation to the censored time-to-event outcome "death from any cause"
timeFrame: from index surgery to censoring date 12.31.2018
measure: Assess whether adding suPAR, hsCRP or combined suPAR+hsCRP measurements improves predictive accuracy of EuroSCORE II
timeFrame: from index surgery to 30 days postoperative
measure: 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"
timeFrame: from index surgery to 30 days postoperative
measure: 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"
timeFrame: from index surgery to 30 days postoperative
Other outcomes:
measure: 30 days mortality measured by a yes/no question of "all-cause mortality"
timeFrame: from index surgery to 30 days
measure: 1-year mortality measured by a yes/no question of "all-cause mortality"
timeFrame: from index surgery to 1 year
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiothoracic Anaesthesiology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Sebastian R Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
References: