Clinical trial NCT05199025: Biomarkers in Perioperative Management
Official title: Biomarkers to Guide Perioperative Management and Improve Outcome in High-risk Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Quality of Life
Death
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2022-01-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients undergoing surgery in the St. Antonius Hospital and the Amphia hospital.

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

Primary outcomes:
measure: Postoperative complication
timeFrame: 30 days
Secondary outcomes:
measure: Failure to rescue
timeFrame: 30 days
measure: Mortality
timeFrame: 120 days
measure: DAH120
timeFrame: 120 days
measure: Disability
timeFrame: 120 days
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia Hospital
state: Brabant
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
Study officials:
References: