Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT06116656
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2023-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Host Gene Expression to Differentiate Between Systemic Inflammation and Infection After Major Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples collected in PAX gene blood RNA tube.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2023-10-30', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative infection', 'timeFrame': '30 days', 'description': 'Infection after surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative SIRS', 'timeFrame': '30 days', 'description': 'SIRS after surgery'}, {'measure': 'Postoperative sepsis', 'timeFrame': '30 days', 'description': 'Sepsis after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infections', 'Sepsis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nObjective: To validate the early diagnostic performance of specific gene signatures1 for differentiating infection from non-infected SIRS or uncomplicated postoperative course.\n\nStudy 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.\n\nNature 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing major noncardiac surgery with infection risk \\>20%', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Major noncardiac surgery with infection risk \\>20%\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Emergency surgery\n* Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06116656', 'acronym': 'PAX', 'briefTitle': 'Changes in Host Gene Expression to Differentiate Between Systemic Inflammation and Infection After Major Surgery', 'organization': {'class': 'OTHER', 'fullName': 'St. Antonius Hospital'}, 'officialTitle': 'Changes in Host Gene Expression to Differentiate Between Systemic Inflammation and Infection After Major Surgery', 'orgStudyIdInfo': {'id': 'NL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood leucocyte transcriptomics', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['not apllicable'], 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Breda', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'T Rettig', 'role': 'CONTACT', 'email': 'trettig@amphia.nl', 'phone': '076-5955000'}], 'facility': 'Amphia hospital', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Nieuwegein', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'P Noordzij PI', 'role': 'CONTACT', 'email': 'p.noordzij@antoniusziekenhuis.nl', 'phone': '0031883206948'}], 'facility': 'St Antonius hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'centralContacts': [{'name': 'Peter Noordzij', 'role': 'CONTACT', 'email': 'p.noordzij@antoniusziekenhuis.nl', 'phone': '+31883203000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amphia Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'dr. P. Noordzij', 'investigatorAffiliation': 'St. Antonius Hospital'}}}}