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| Name | Class |
|---|---|
| Roche Diagnostics GmbH | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker | Diagnostic Test | Perioperative biomarker analyses |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complication | a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Failure to rescue | In-hospital death following a major complication | 30 days |
| Mortality | Death | 120 days |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients undergoing surgery in the St. Antonius Hospital and the Amphia hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Noordzij | Contact | 0031883203000 | p.noordzij@antoniusziekenhuis.nl | |
| Thijs Rettig | Contact | 0031883203000 | trettig@amphia.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphia Hospital | Recruiting | Breda | North Brabant | 4818CK | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41768076 | Derived | Reniers T, Noordzij P, Harding E, Ruven H, Thio M, Langelaan M, Dijkstra I, Vernooij L, Cremer O, Rettig TCD. Procalcitonin and interleukin-6 to diagnose infection in cardiac surgery patients with hyperinflammation: a two-centre, prospective cross-sectional study. BJA Open. 2026 Feb 19;17:100538. doi: 10.1016/j.bjao.2026.100538. eCollection 2026 Mar. | |
| 38862228 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074062 | Environmental Biomarkers |
| ID | Term |
|---|---|
| D015415 | Biomarkers |
| D001685 | Biological Factors |
| D001686 | Biological Phenomena |
| D004784 | Environmental Monitoring |
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Human blood samples
| DAH120 | Days alive and out of hospital | 120 days |
| Disability | Change in disability according to WHODAS 2.0 - 12 item | 120 days |
| St Antonius Hospital | Recruiting | Nieuwegein | Utrecht | 3430 EM | Netherlands |
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| Noordzij PG, Ruven HJ, Reniers T, Idema RN, Thio MS, Cremer OL, Hollema N, Smit KN, Vernooij LM, Dijkstra IM, Rettig TC. Cohort profile of BIGPROMISE: a perioperative biobank of a high-risk surgical population. BMJ Open. 2024 Jun 11;14(6):e078307. doi: 10.1136/bmjopen-2023-078307. |
| D004781 |
| Environmental Exposure |
| D004787 | Environmental Pollution |
| D011634 | Public Health |
| D004778 | Environment and Public Health |