NCT06116656

Changes in Host Gene Expression to Differentiate Between Systemic Inflammation and Infection After Major Surgery

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infections
• Sepsis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	blood leucocyte transcriptomics	the analysis of the RNA transcripts produced by the genotype at a given time that provides a link between the genome, the proteome, and the cellular phenotype.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2023-11-03
• Last updated: 2024-12-16

Locations

2 sites across 1 country: Netherlands