Actively Recruiting

Age: 18Years +
All Genders
ID05199025

Biomarkers to Guide Perioperative Management and Improve Outcome in High-risk Surgery

Led by St. Antonius Hospital · Updated on 2026-04-27

5000

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

S

St. Antonius Hospital

Lead Sponsor

R

Roche Diagnostics GmbH

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Biomarkers in Perioperative Management

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Undergoing elective cardiac surgery (isolated coronary artery bypass grafting or single valve surgery)
  • Undergoing elective gastrointestinal surgery (colorectal, pancreatic, gastric surgery)
  • Undergoing elective vascular surgery (open and endovascular aortic surgery, peripheral vascular surgery)
  • Undergoing elective lung surgery (pneumonectomy, lobectomy, segmentectomy)
Not Eligible

You will not qualify if you...

  • Younger than 18 years
  • Pregnant
  • Emergency surgery
  • No informed consent given

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Perioperative period

Participants undergo perioperative biomarker analyses to guide management.

1 to 2 visits depending on surgery type

Long-term Monitoring

Duration - Up to 120 days post-surgery

Participants are monitored for postoperative complications and outcomes after surgery.

Follow-up visits up to 120 days

Trial Site Locations

Total: 2 locations

1

Amphia Hospital

Breda, North Brabant, Netherlands, 4818CK

Actively Recruiting

2

St Antonius Hospital

Nieuwegein, Utrecht, Netherlands, 3430 EM

Actively Recruiting

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Research Team

P

Peter Noordzij

T

Thijs Rettig

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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/41768076