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Completed

NCT Number: NCT04292249

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

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.

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Key information

Conditions

Thoracic Surgery Biomarkers Cardiac Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiothoracic Anaesthesiology, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Other

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.

Primary outcomes

  1. Association of preoperative suPAR values in relation to the censored time-to-event outcome "death from any cause"

    Time frame: from index surgery to censoring date 12.31.2018

Secondary outcomes

  1. Association of preoperative hsCRP values in relation to the censored time-to-event outcome "death from any cause"

    Time frame: from index surgery to censoring date 12.31.2018

  2. Assess whether adding suPAR, hsCRP or combined suPAR+hsCRP measurements improves predictive accuracy of EuroSCORE II

    Time frame: from index surgery to 30 days postoperative

  3. 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"

    Time frame: from index surgery to 30 days postoperative

  4. 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"

    Time frame: from index surgery to 30 days postoperative

Other outcomes

  1. 30 days mortality measured by a yes/no question of "all-cause mortality"

    Time frame: from index surgery to 30 days

  2. 1-year mortality measured by a yes/no question of "all-cause mortality"

    Time frame: from index surgery to 1 year

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Persimune
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2020
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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