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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292249
• Other study ID #: H-18002379
• Status: Completed
• Start date: August 6, 2012
• Est. completion date: December 16, 2019

Study information

• Verified date: February 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 951
• Est. completion date: December 16, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomarkers
• Cardiac Surgical Procedures
• Thoracic Surgery

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Cardiothoracic Anaesthesiology, Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Persimune, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30 days mortality measured by a yes/no question of "all-cause mortality"		from index surgery to 30 days
Other	1-year mortality measured by a yes/no question of "all-cause mortality"		from index surgery to 1 year
Primary	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	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
Secondary	Assess whether adding suPAR, hsCRP or combined suPAR+hsCRP measurements improves predictive accuracy of EuroSCORE II		from index surgery to 30 days postoperative
Secondary	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
Secondary	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