Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-05 @ 5:48 PM
Study NCT ID:
NCT02881268
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of immunosuppression biomarkers in septic and non-septic patients hospitalized in intensive care unit', 'timeFrame': 'Day 14'}], 'secondaryOutcomes': [{'measure': 'Association of immunosuppression biomarkers with occurrence of events reflecting a clinical immunosuppression', 'timeFrame': 'Day 14', 'description': 'Study of CMV reactivation and nosocomial infections'}, {'measure': 'Association of immunosuppression biomarkers with patients demographic data', 'timeFrame': 'Day 14', 'description': 'Record of patient age and gender'}, {'measure': 'Association of immunosuppression biomarkers with patients clinical data', 'timeFrame': 'Day 14', 'description': 'Record of severity score, duration of hospitalization, duration of mechanical ventilation, morbidity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patient Hospitalized in Intensive Care Unit']}, 'descriptionModule': {'briefSummary': 'Open-label, non-randomized, prospective, single center, observational, translational study', 'detailedDescription': 'The aim of this trial is to study immunosuppression biomarkers in patients hospitalized in intensive care unit in comparison to non-septic patients.\n\nPrevalence of immunosuppression acquired in intensive care unit will be studied and patients most likely to develop nosocomial infection will be early identified'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient hospitalized in intensive care unit with or without sepsis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient older than 18 years old\n* Patient hospitalized in intensive care unit for any reason\n* Patient with infection started less than 5 days before admission\n* Patient with mechanical ventilation or not\n* Patient with arterial catheter for an invasive monitoring of blood pressure\n* Patient informed about the study protocol and approved to participate.\n* Patients hospitalized for a severe bacterial infection (severe sepsis or septic shock)\n* Patient hospitalized for a non-infectious disease\n\nExclusion Criteria:\n\n* Pregnancy\n* Advanced immunosuppression defined by proved humoral or cellular impairment by continuous administration of steroids at any dose since more than one month before hospitalization, transplantation, radiotherapy or chemotherapy in the preceding year\n* Initiation of an immunosuppressive therapy as chemotherapy, cyclophosphamide or high dose corticotherapy (\\>0.5mg/kg/day)'}, 'identificationModule': {'nctId': 'NCT02881268', 'acronym': 'IMPRIM', 'briefTitle': 'Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit', 'orgStudyIdInfo': {'id': '35RC15_9903_IMPRIM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with sepsis', 'description': 'Patient hospitalized in intensive care unit', 'interventionNames': ['Other: blood sample']}, {'label': 'Patient without sepsis', 'description': 'Patient hospitalized in intensive care unit', 'interventionNames': ['Other: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'OTHER', 'armGroupLabels': ['Patient with sepsis', 'Patient without sepsis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}