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

NCT06116656 | Terminated

• 1 other identifier: NL
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Infections; Sepsis

Outcome Measures

Primary Outcomes (1)

• Postoperative infection

  Infection after surgery

  30 days

Secondary Outcomes (2)

• Postoperative SIRS

  30 days

• Postoperative sepsis

  30 days

Interventions

blood leucocyte transcriptomics DIAGNOSTIC_TEST

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.

Also known as: not apllicable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing major noncardiac surgery with infection risk \>20%

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Antonius Hospital: lead
• Amphia Hospital: collaborator

Study Sites (2)

Amphia hospital

Breda, Netherlands

Location

St Antonius hospital

Nieuwegein, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected in PAX gene blood RNA tube.

MeSH Terms

Conditions

Infections; Sepsis

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)