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

NCT04292249 | Completed

• 1 other identifier: H-18002379
• Study Type: observational
• Target: 951
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery; Cardiac Surgical Procedures; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (1)

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

Interventions

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.

Elective on-pump cardiac surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Peroperatively cancelling the surgery
• Sudden change to off-pump coronary artery bypass (OPCAB) surgery
• Death prior to surgery
• Project blood samples not available.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Persimune: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Department of Cardiothoracic Anaesthesiology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples: The blood samples for the study were drawn preoperatively or within 24 hours of surgery and stored in the Persimune Biobank or two other biobanks at Dept. Cardiothoracic Anaesthesiology and Dept. Cardiothoracic Surgery, Rigshospitalet.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sebastian R Rasmussen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 3, 2020
• Study Start: August 6, 2012
• Primary Completion: June 11, 2019
• Study Completion: December 16, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-02

Locations

DK (1)