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

Sepsis Clinical Trial

— PAX  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06116656
• Other study ID #: NL
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: November 2023
• Source: St. Antonius Hospital
• Contact: Peter Noordzij
• Phone: +31883203000
• Email: p.noordzij[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Major noncardiac surgery with infection risk >20%

Exclusion Criteria:

• Age <18 years

• Emergency surgery

• Inability to provide informed consent.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Inflammation
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St. Antonius Hospital	Amphia Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative infection	Infection after surgery	30 days
Secondary	Postoperative SIRS	SIRS after surgery	30 days
Secondary	Postoperative sepsis	Sepsis after surgery	30 days