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

Completed

• Conditions: Thoracic Surgery; Cardiac Surgical Procedures; Biomarkers
• Interventions: Other: Blood sampling

• Registration Number: NCT04292249
• Lead Sponsor: Rigshospitalet, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-06
• Primary Completion: 2019-06-11
• Study Completion: 2019-12-16
• Status Verified: 2020-02
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Study First Posted: 2020-03-03
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 951

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elective on-pump cardiac surgery patients	Blood sampling	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Cardiothoracic Anaesthesiology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark