Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-03-13 @ 9:56 AM
Study NCT ID:
NCT03085459
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2017-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Nursing Staff on Empiric Antibiotic in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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': 'D012769', 'term': 'Shock'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-14', 'studyFirstSubmitDate': '2017-01-31', 'studyFirstSubmitQcDate': '2017-03-14', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compliance of empiric antibiotic treatment within first hour', 'timeFrame': '1 hour', 'description': 'compliance of empiric antibiotic treatment within first hour'}, {'measure': 'evaluate the effect of nursing stuff on the compliance', 'timeFrame': '1 hour', 'description': 'evaluate the effect of nursing stuff on the compliance'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septic Shock', 'Compliance', 'Antibiotic', 'Nursing Caries']}, 'descriptionModule': {'briefSummary': 'A retrospective, observational study was performed about the patients with septic shock who admitted into intensive care unit (ICU) from January 1, 2015 to February 29, 2016. The number of patients who received empiric antibiotic treatment within first hour after septic shock diagnosis were collected. Detailed information about clinical ladder for nursing stuff and nursing shift were collected . Clinical ladder for nursing stuff is a new definition based on education background and work experience and nurses stuff are classified into four levels. N0 was defined who got college degree or above, nurse qualification certificate and working time less than one year. N1 an N2 were defined as who got nurse qualification certificate and working time between 1\\~3 years and more than three years, respectively. N3 was defined who was nurse-in-charge qualification or got nurse practitioner qualification for more than five years. Compliance of empiric antibiotic treatment within first hour and evaluate the effect of nursing stuff on the compliance were calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients whose age of 18 years or older admitted to the ICU with septic shock from between January 01, 2015 to February 29, 2016', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\>18 years old\n* sepsis\n\nExclusion Criteria:\n\n* pregnancy\n* \\>80 years old.'}, 'identificationModule': {'nctId': 'NCT03085459', 'briefTitle': 'Effects of Nursing Staff on Empiric Antibiotic in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'The Effect of Nursing Staff on Empiric Antibiotic Treatment Within the First Hour in Patients With Septic Shock: A Retrospective Study', 'orgStudyIdInfo': {'id': 'Nurse: empiric antibiotic'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nurse level N0', 'description': 'who got college degree or above, nurse qualification certificate and working time less than one year', 'interventionNames': ['Behavioral: work Time']}, {'label': 'Nurse level N1', 'description': 'who got nurse qualification certificate and working time between 1\\~3 years', 'interventionNames': ['Behavioral: work Time']}, {'label': 'Nurse level N2', 'description': 'who got nurse qualification certificate and working time between 3\\~5 years', 'interventionNames': ['Behavioral: work Time']}, {'label': 'Nurse level N3', 'description': 'who got nurse qualification certificate and working time more than 5 years', 'interventionNames': ['Behavioral: work Time']}], 'interventions': [{'name': 'work Time', 'type': 'BEHAVIORAL', 'description': 'nurse got qualification certificate and the working time', 'armGroupLabels': ['Nurse level N0', 'Nurse level N1', 'Nurse level N2', 'Nurse level N3']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chun Pan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chun Pan', 'investigatorAffiliation': 'Southeast University, China'}}}}