Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT05610020
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2022-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heparin Binding Protein as a Prognostic Biomarker of Sepsis Severity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-05', 'studyFirstSubmitDate': '2022-10-20', 'studyFirstSubmitQcDate': '2022-11-05', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the level of Heparin binding protein in relation to patient clinical improvement measured by SOFA Score', 'timeFrame': '72 hours after meeting sepsis ceriteria', 'description': 'Correlates the change of the level of Heparin binding protein in ng/ml to the clinical improvement of the patients which is measured by SOFA score'}], 'secondaryOutcomes': [{'measure': 'Heparin binding protein and mortality', 'timeFrame': '28 days after meeting sepsis ceriteria', 'description': 'Correlates the change of the level of Heparin binding protein in ng/ml And how can it is used to predict mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'HBP']}, 'descriptionModule': {'briefSummary': 'the aim of the study is to correlate between the severity of sepsis and serum heparin binding protein in the patients admitted to ICU with sepsis., and detect its value as a prognostic biomarker in sepsis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult confirmed septic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult whose age between 20 to70 years old\n* patients suffered from sepsis or septic shock (under the third international consensus definition of sepsis and septic shock)\n\nExclusion Criteria:\n\n* Any pregnancy female\n* Any patient who is Neutropenic secondary to malignancy\n* Patients who is taking immunosuppressive therapy\n* Patients who is suffering fromHematological malignancy'}, 'identificationModule': {'nctId': 'NCT05610020', 'briefTitle': 'Heparin Binding Protein as a Prognostic Biomarker of Sepsis Severity', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Heparin Binding Protein as a Reliable Prognostic Biomarker for Severity of Sepsis in the Intensive Care Unit', 'orgStudyIdInfo': {'id': 'FMASU M D 159/ 2021'}}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Omar Hamdy', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist intensive care medicine', 'investigatorFullName': 'Omar Hamdy', 'investigatorAffiliation': 'Ain Shams University'}}}}