Clinical trial NCT06116656: Changes in Host Gene Expression to Differentiate Between Systemic Inflammation and Infection After Major Surgery
Official title: Changes in Host Gene Expression to Differentiate Between Systemic Inflammation and Infection After Major Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infections
Sepsis
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Amphia Hospital
First posted: 2023-11-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing major noncardiac surgery with infection risk \>20%

Brief summary: Changes in host gene expression may provide additional information to diagnose postoperative infection and improve outcome after surgery. This study aims to validate the early diagnostic performance of specific gene signatures for differentiating infection from non-infected SIRS or uncomplicated postoperative course in blood sampes of adult patients undergoing major noncardiac surgery.

Detailed description: Rationale: Differentiation between the systemic inflammatory response syndrome (SIRS) and infection after surgery is challenging. Consequent diagnostic uncertainty may result in delayed diagnosis and interventions to prevent organ dysfunction or eventually death. Changes in host gene expression may provide additional information to diagnose postoperative infection and improve outcome after surgery.

Objective: To validate the early diagnostic performance of specific gene signatures1 for differentiating infection from non-infected SIRS or uncomplicated postoperative course.

Study design: A prospective observational multicenter study. Study population: Adult patients undergoing major noncardiac surgery. Main study parameters/endpoints: Main study parameters are specific gene signatures. Main study endpoint is postoperative infection and SIRS.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In each patient blood samples will be drawn for analysis on the following time points: after induction for anaesthesia, directly postoperative and on postoperative day 1 - 7. For each sample 2.5 ml of blood is taken. In a total of 9 samples this results in a cumulative volume of 22.5 ml. Whenever possible, blood samples will be drawn simultaneously with routine perioperative laboratory testing. In case of admission 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:

* Age \>18 years
* Major noncardiac surgery with infection risk \>20%

Exclusion Criteria:

* Age \<18 years
* Emergency surgery
* Inability to provide informed consent.

Primary outcomes:
measure: Postoperative infection
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative SIRS
timeFrame: 30 days
measure: Postoperative sepsis
timeFrame: 30 days
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia hospital
city: Nieuwegein
country: Netherlands
facility: St Antonius hospital
Study officials:
References: