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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-06-01

Brief Summary

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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

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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

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Infections Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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not apllicable

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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dr. P. Noordzij

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amphia hospital

Breda, , Netherlands

Site Status RECRUITING

St Antonius hospital

Nieuwegein, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Peter Noordzij

Role: CONTACT

Phone: +31883203000

Email: [email protected]

Facility Contacts

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T Rettig

Role: primary

P Noordzij PI