Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
Study NCT ID:
NCT03626961
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2018-08-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of NEWS on Intensive Care Discharges
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010359', 'term': 'Patient Readmission'}, {'id': 'D004322', 'term': 'Drainage'}], 'ancestors': [{'id': 'D006760', 'term': 'Hospitalization'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 538}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Readmission rate', 'timeFrame': '48 hours', 'description': 'Clinical deterioration within 48 hours after ICU transfer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NEWS'], 'conditions': ['Intensive Care']}, 'descriptionModule': {'briefSummary': 'To determine the ability of the NEWS at tertiary intensive care unit discharges to predict the development of clinical deterioration.\n\nTo determine a cut-off value for NEWS score for early readmission', 'detailedDescription': 'The Nationaly Early Warning Score (NEWS) is a single score based on the measurement of vital signs and inspired gases by the patient. A higher NEWS indicates severity of illness and risk of adverse outcomes. The use of NEWS values to select the appropriate patients for tertiary ICU discharges has not been tested. Our aim is to test the value of NEWS on discharges tertiary ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Surgical and medical patients who met the criteria of the tertiary stage intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years old\n* Stay higher than 48 hours\n\nExclusion Criteria:\n\n* Under 18 years old\n* Stay lower than 48 hours\n* Intoxication\n* Exitus'}, 'identificationModule': {'nctId': 'NCT03626961', 'briefTitle': 'The Role of NEWS on Intensive Care Discharges', 'organization': {'class': 'OTHER', 'fullName': 'Hitit University'}, 'officialTitle': 'The Role of NEWS on Tertiary Intensive Care Discharges', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'discharge', 'description': 'patients discharged from icu', 'interventionNames': ['Other: readmission', 'Other: discharge']}, {'label': 'readmission', 'description': 'patients readmitted icu in 48 hours after icu discharge', 'interventionNames': ['Other: readmission', 'Other: discharge']}], 'interventions': [{'name': 'readmission', 'type': 'OTHER', 'description': 'Readmission after 48 hours', 'armGroupLabels': ['discharge', 'readmission']}, {'name': 'discharge', 'type': 'OTHER', 'description': 'Discharge', 'armGroupLabels': ['discharge', 'readmission']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19100', 'city': 'Çorum', 'state': 'Çorum', 'country': 'Turkey (Türkiye)', 'facility': 'Hitit university', 'geoPoint': {'lat': 40.54889, 'lon': 34.95333}}], 'overallOfficials': [{'name': 'Ozgur Yagan, Assoc.Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hitit universtiy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Our regulations forbid to share the IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hitit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Selcuk KAYIR', 'investigatorAffiliation': 'Hitit University'}}}}