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Recruiting NCT05199025

Biomarkers in Perioperative Management

— Observational Postoperative Complications Quality of Life Death

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biomarker.
Who it may be relevant to
Registry conditions: Postoperative Complications, Quality of Life, Death. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test Biomarker
    Perioperative biomarker analyses

Primary outcome measures

  • Postoperative complication [Time frame: 30 days]
Secondary outcome measures (4)
  • Failure to rescue [Time frame: 30 days]
  • Mortality [Time frame: 120 days]
  • DAH120 [Time frame: 120 days]
  • Disability [Time frame: 120 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 2 centers
  • Amphia Hospital — Breda
  • St Antonius Hospital — Nieuwegein

Publications

  • 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. PMID 41768076
  • 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. PMID 38862228

Identifiers

NCT: NCT05199025 · NL7407610020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗