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

April 22, 2026 updated by: dr. P. Noordzij, St. Antonius Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Breda, Netherlands
        • Amphia Hospital
      • Nieuwegein, Netherlands
        • St Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative infection
Time Frame: 30 days
Infection after surgery
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative SIRS
Time Frame: 30 days
SIRS after surgery
30 days
Postoperative sepsis
Time Frame: 30 days
Sepsis after surgery
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Collaborators

Amphia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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