MedTrace Logo

Biomarkers in Perioperative Management

NCT05199025 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-04-27

No results posted yet for this study

Summary

Rationale: The rate of postoperative complications after high-risk surgery remains high despite recent advances in perioperative management. There is a lack of objective and reliable information that can be used for risk stratification and to guide treatment decisions.

Objective: To describe the perioperative biomarker response in surgical patients with and without a postoperative complication and construct a preoperative and postoperative prediction model for postoperative complications. To systematically collect perioperative blood samples and clinical data in high-risk surgical patients for the development en analysis of biomarkers.

Study design: Multicenter, prospective, observational study. Study population: 4819 patients undergoing elective cardiac, colorectal, vascular and lung surgery.

Intervention (if applicable): Not applicable. Main study parameters/endpoints: Main study parameters are levels of PCT, CRPhs, IL-6, GDF-15, sFLT, NT-proBNP, cTNThs, CysC and NGAL. Main study endpoint is the occurrence of a major postoperative complication which is defined as a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death within 30 days of surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In each patient five blood samples will be drawn for analysis. Most of the blood samples are drawn simultaneously with routine perioperative laboratory testing, which is common in this study population. In case a patient is admitted to the Intensive Care Unit blood samples will be collected using an arterial line. There are no direct risks or benefits for patients included in the study.

Conditions

  • Postoperative Complications
  • Quality of Life
  • Death

Interventions

DIAGNOSTIC_TEST

Biomarker

Perioperative biomarker analyses

Sponsors & Collaborators

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • St. Antonius Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2026-06-01
Completion
2026-12-01

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05199025 on ClinicalTrials.gov