Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT04767893
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2021-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic and Prognostic Biomarkers of Sepsis
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': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-21', 'studyFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2021-02-21', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS', 'timeFrame': 'in the 1st day after appearance of clinical signs of infection', 'description': 'by ELISA"enzyme linked immunosorbent assay"'}, {'measure': 'Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS', 'timeFrame': 'in the 7th day after appearance of clinical signs of infection', 'description': 'by ELISA"enzyme linked immunosorbent assay"'}, {'measure': 'Measurement of the serum level of sUPAR (ng/L) in the ICU patients', 'timeFrame': 'in the 1st day after appearance of clinical signs of infection', 'description': 'by ELISA"enzyme linked immunosorbent assay"'}, {'measure': 'Measurement of the serum level of sUPAR (ng/L) in the patients with criteria of SIRS', 'timeFrame': 'in the 7th day after appearance of clinical signs of infection', 'description': 'by ELISA"enzyme linked immunosorbent assay"'}, {'measure': 'Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS', 'timeFrame': 'in the 1st day after appearance of clinical signs of infection', 'description': 'by turbidimetry'}, {'measure': 'Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS', 'timeFrame': 'in the 7th day after appearance of clinical signs of infection', 'description': 'by turbidimetry'}], 'secondaryOutcomes': [{'measure': 'Acute Physiology and Chronic Health Evaluation II (APACHE II) score designed to measure the severity of disease for adult patients admitted to intensive care units in the with criteria of SIRS', 'timeFrame': 'in the 7th day after appearance of clinical signs of infection', 'description': 'an integer score from 0 to 71'}, {'measure': 'The sequential organ failure assessment score (SOFA score) had been used to determine the extent of organ dysfunction of ICU patients with criteria of SIRS', 'timeFrame': 'in the 7th day after appearance of clinical signs of infection', 'description': '0-\\<11'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sTREM-1', 'sUPAR', 'CRP'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate sepsis biomarkers as soluble triggering receptor expressed on myeloid cells 1 (sTREM-1) and soluble urokinase plasminogen activator receptor (sUPAR) in diagnosis of sepsis in comparison to the traditional blood culture and C-reactive protein (CRP) and to evaluate the prognostic value of these biomarkers in comparison to sequential organ failure assessment score (SOFA score), Acute Physiology and Chronic Health Evaluation II ( APACHI score), 28 day mortality.', 'detailedDescription': 'Sepsis is usually diagnosed in patients have clinically suspected infections with systemic inflammatory response syndrome (SIRS) manifestations. Patients with SIRS as those with trauma or stroke have the same classic infection signs such as fever and elevated leukocytic count, as long as the microbiological diagnosis is the ultimate diagnostic method, but it has poor sensitivity with delayed results. New biomarkers such as sTREM-1 and sUPAR can be used for rapid diagnosis of sepsis and differentiating it from non infectious inflammatory syndromes. Also these soluble biomarkers can be used for predicting the prognosis of sepsis patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Our study was conducted on patients admitted to different ICUs in Sohag University Hospital who develop possible clinical signs of sepsis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Temperature of \\>38oC\n* Heart rate of \\>90 beats/min\n* Respiratory rate of \\>20 breaths/min\n* Partial pressure of arterial carbon dioxide (PaCO2) of \\<32 mmHg\n* White blood cell (WBC) count of \\>12,000 cells/mm3\n\nExclusion Criteria:\n\n* HIV patients\n* Patients with neutropenia \\<1000 cells/mm3\n* \\<18 years of age.'}, 'identificationModule': {'nctId': 'NCT04767893', 'briefTitle': 'Diagnostic and Prognostic Biomarkers of Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Evaluation of the Role of sTREM-1 and sUPAR Biomarkers as a Diagnostic Tool and Prognostic Predictor in Sepsis Patients', 'orgStudyIdInfo': {'id': 'Soh-Med-21-02-18'}}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Faculty of medicine - sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Nahed Fathallah, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of medical microbiology & immunology departement -faculty of medicine', 'investigatorFullName': 'Nahed Fathallah Fahmy', 'investigatorAffiliation': 'Sohag University'}}}}