Elevated preoperative suPAR is a strong and independent risk marker for postoperative complications in high-risk patients undergoing major non-cardiac surgery (SPARSE)

ABSTRACT

Background Patients undergoing major surgery are often at risk of developing postoperative complications. We investigated whether the inflammatory biomarker suPAR can aid in identifying patients at high risk for postoperative complications, morbidity, and mortality.

Methods In this prospective observational study (ClinicalTrials.gov identifier: NCT03851965), peripheral venous blood was collected from consecutive adult patients scheduled for major non-cardiac surgery with expected duration ≥2 hours under general anesthesia. Patients fulfilling the following inclusion criteria were included: age ≥18 years and American Society of Anesthesiologists’ physical status I to IV. Plasma suPAR levels were determined using the suPARnostic® quick triage lateral flow assay. The primary endpoint was post-operative complications defined as presence of any complication and/or admission to intensive care unit and/or mortality within the first 90 postoperative days.

Results Preoperative suPAR had an OR of 1.50 (95%CI 1.24-1.82) for every ng/ml increase (AUC 0.82, 95%CI: 0.72-0.91). When including age, sex, ASA score, CRP, and grouped suPAR in multivariate analysis, patients with suPAR between 5.5 and 10 ng/ml had an OR of 12.7 (CI: 3.6-45.5) and patients with suPAR>10 ng/ml had an OR of 20.7 (CI: 4.5-95.4) compared to patients with suPAR≤5.5 ng/ml, respectively. ROC analysis including age, sex, CRP levels, and ASA score and had an AUC of 0.69 (95%CI: 0.58-0.80). When suPAR was added to this Model, the AUC increased to 0.84 (0.74-0.93) (p=0.009).

Conclusions Preoperative suPAR provided strong and independent predictive value on postoperative complications in high-risk patients undergoing major non-cardiac surgery.

Competing Interest Statement

Jesper Eugen-Olsen is a co-founder, shareholder and CSO of ViroGates A/S and is mentioned inventor on patents on suPAR owned by Copenhagen University Hospital Hvidovre, Denmark. All other authors report no conflicts of interest.

Clinical Trial

NCT03851965

Funding Statement

No funding received.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval for this study was provided by the Ethical Committee of the University Hospital of Larisa, Larisa, Greece (IRB no. 60580/11-12-2018). The study was registered at ClinicalTrials.gov (NCT03851965) and was performed according to national and international guidelines. Written informed consent was obtained from all patients.

All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

Data from SPARSE can be made available upon request through a collaborative process. Please contact the corresponding author for additional information.

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