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

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

Study Overview

• Status: Completed
• Conditions: Biomarkers; Thoracic Surgery; Cardiac Surgical Procedures
• Intervention / Treatment: Other: Blood sampling

• Study Type: Observational
• Enrollment (Actual): 951

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Cardiothoracic Anaesthesiology, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: University of Copenhagen; Persimune
• Investigators: Principal Investigator: Sebastian R Rasmussen, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2012
• Primary Completion (Actual): June 11, 2019
• Study Completion (Actual): December 16, 2019

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: H-18002379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No