Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-28 @ 10:37 AM
Study NCT ID:
NCT03881566
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2019-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma, Blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2019-03-09', 'studyFirstSubmitQcDate': '2019-03-16', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between immunocompetent and immunocompromised patients.', 'timeFrame': 'up to 7 days', 'description': 'For the analysis, plasma presepsin levels on Day 0 will be used. Sepsis was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between immunocompromised and immunocompetent patients is compared to that of procalcitonin.'}], 'secondaryOutcomes': [{'measure': 'survival at ICU discharge or day 28 after enrollment', 'timeFrame': '28 days', 'description': 'For the analysis, we will evaluate the association between presepsin and survival at ICU discharge or day 28 after enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Immune Deficiency']}, 'descriptionModule': {'briefSummary': 'This is an observational study to evaluate the diagnostic and prognostic value of presepsin in the critically-ill immunocompromise patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with presentation to ICU with critical illness compatible with sepsis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged ≥ 19 years\n* Appropriate clinical data to enable classification into sepsis\n* Written informed consent by the patient or legally authorized representative\n* Critical illness consistent with sepsis, to be enrolled within 24 hours of presentation\n\nExclusion Criteria:\n\n* No informed consent\n* A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability'}, 'identificationModule': {'nctId': 'NCT03881566', 'acronym': 'PREICU', 'briefTitle': 'Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Study of Usefulness of Presepsin as Early Detective Marker of Sepsis in Immunodeficiency ICU Patients', 'orgStudyIdInfo': {'id': 'PRESEPSIN_IMMUNODIFFICIENCY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immunocompetent sepsis patients', 'description': 'Sepsis patients without HIV infection (all stages), neutropenia (neutrophil count \\< 1 × 109/L), exposure to glucocorticoids (\\> 0.5 mg/kg for \\> 30 d) and/or immunosuppressive or cytotoxic medications, solid organ transplantation, allogeneic or autologous stem cell transplantation, hematological malignancy, or solid tumor.'}, {'label': 'Immunocompromised sepsis patients', 'description': 'Sepsis patients with HIV infection (all stages), neutropenia (neutrophil count \\< 1 × 109/L), exposure to glucocorticoids (\\> 0.5 mg/kg for \\> 30 d) and/or immunosuppressive or cytotoxic medications, solid organ transplantation, allogeneic or autologous stem cell transplantation, hematological malignancy, or solid tumor.'}, {'label': 'Patients without sepsis', 'description': 'Patients who admitted intensive care unit without sepsis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jongmin Lee, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jongmin Lee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jongmin Lee', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}