Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-01 @ 1:23 AM
Study NCT ID:
NCT02120534
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2014-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum CD14 and CD88 Mointoring in ICU
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-14', 'studyFirstSubmitDate': '2014-04-18', 'studyFirstSubmitQcDate': '2014-04-18', 'lastUpdatePostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A serum soluble CD14', 'timeFrame': 'one week', 'description': 'At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 will be monitored.'}], 'secondaryOutcomes': [{'measure': 'Survival of ICU patients', 'timeFrame': 'Two weeks', 'description': 'Correlation of of serum soluble CD14 and the corresponding changes of serum CD88 and their correlation in critically ill sepsis and SIRS patients and survival.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['soluble CD14 ,serum CD88,sepsis , SIRS.'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The present study will be conducted to determine the dynamic changes of serum soluble CD14 and the corresponding changes of serum CD88 and their correlation in critically ill sepsis and SIRS patients.', 'detailedDescription': 'A total of ninty four will be included in the study. Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of ninety-four patients will be included in the study. Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients staying in ICU for more than 24 hours will be included in the study.\n\nExclusion Criteria:\n\n* Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT02120534', 'briefTitle': 'Serum CD14 and CD88 Mointoring in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Predictive Values of Serum Soluble CD14 Subtype and CD88 Monitoring in Critically Ill Patients.', 'orgStudyIdInfo': {'id': '1638/02/13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis group', 'description': 'Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.'}, {'label': 'SIRS group', 'description': 'Forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35217', 'city': 'Tanta', 'state': 'Algharbyia', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Ayman A Yousef, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ayman Abd Al-maksoud Yousef', 'investigatorAffiliation': 'Tanta University'}}}}