| NCT ID | NCT05199025 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Antonius Hospital |
| Condition | Postoperative Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2021-10-12 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2021-10-12 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Cardiac surgery (isolated coronary artery bypass grafting or combined with single valve surgery, isolated single valve surgery) * Gastrointestinal surgery (colorectal, pancreatic, gastric surgery). * Vascular surgery (open and endovascular aortic surgery, peripheral vascular surgery) * Lung surgery (pneumonectomy,(bi)(sleeve)lobectomy or segmentectomy) Exclusion Criteria: * Age \< 18 years * Pregnancy * Emergent surgery * No informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05199025 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05199025 currently recruiting?
Yes, NCT05199025 is actively recruiting participants. Contact the research team at p.noordzij@antoniusziekenhuis.nl for enrollment information.
Where is the NCT05199025 trial being conducted?
This trial is being conducted at Breda, Netherlands, Nieuwegein, Netherlands.
Who is sponsoring the NCT05199025 clinical trial?
NCT05199025 is sponsored by St. Antonius Hospital. The trial plans to enroll 5,000 participants.