Procalcitonin and interleukin-6 to diagnose infection in cardiac surgery patients with hyperinflammation: a two-centre, prospective cross-sectional study.
Ted Reniers, Peter Noordzij, Eline Harding...
https://pubmed.ncbi.nlm.nih.gov/41768076Actively Recruiting
Led by St. Antonius Hospital · Updated on 2026-04-27
5000
Participants Needed
2
Research Sites
26 weeks
Total Duration
S
St. Antonius Hospital
Lead Sponsor
R
Roche Diagnostics GmbH
Collaborating Sponsor
Researchers are investigating the use of perioperative biomarkers to better understand and predict complications after high-risk surgeries such as cardiac, colorectal, vascular, and lung surgeries. The study aims to collect detailed information to develop models that can predict major postoperative complications like infections, pneumonia, sepsis, kidney injury, cardiovascular events, or death within 30 days of surgery. This multicenter, prospective, observational study involves 4819 patients undergoing elective surgeries. The study involves collecting blood samples and clinical data before and after surgery to analyze levels of biomarkers including PCT, CRPhs, IL-6, GDF-15, sFLT, NT-proBNP, cTNThs, CysC, and NGAL. Blood samples are taken five times per patient, mostly alongside routine lab tests, and through arterial lines if admitted to the Intensive Care Unit. There are no interventions or treatments; rather, the biomarkers are studied to improve risk prediction and management. Participants will undergo blood draws and routine clinical assessments during their surgical care. Researchers will monitor outcomes such as major postoperative complications within 30 days and longer-term events including mortality and disability up to 120 days. The study also tracks recovery metrics like days alive and at home within 120 days. There is no direct risk or benefit to participants, and data collection occurs alongside standard medical care over the perioperative period.
CONDITIONS
Biomarkers in Perioperative Management
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Perioperative period
Participants undergo perioperative biomarker analyses to guide management.
1 to 2 visits depending on surgery type
Duration - Up to 120 days post-surgery
Participants are monitored for postoperative complications and outcomes after surgery.
Follow-up visits up to 120 days
Total: 2 locations
1
Amphia Hospital
Breda, North Brabant, Netherlands, 4818CK
Actively Recruiting
2
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3430 EM
Actively Recruiting
P
Peter Noordzij
T
Thijs Rettig
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Ted Reniers, Peter Noordzij, Eline Harding...
https://pubmed.ncbi.nlm.nih.gov/41768076Peter G Noordzij, Henk Jt Ruven, Ted Reniers...
https://pubmed.ncbi.nlm.nih.gov/38862228