Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:56 AM
Study NCT ID:
NCT07316894
Status:
RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IWS Diagnosis Criteria Consensus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007362', 'term': 'Intensive Care Units'}, {'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D006757', 'term': 'Hospital Units'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Criteria of IWS', 'timeFrame': '4 monts', 'description': 'The diagnostic criteria of IWS will be determined based on the items reaching the consensus'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iatrogenicwithdrawalsyndrome', 'ICU', 'delphiconsensus'], 'conditions': ['Iatrogenic Withdrawal Syndrome']}, 'referencesModule': {'references': [{'pmid': '40771468', 'type': 'BACKGROUND', 'citation': 'Moisa E, Tuculeanu G, Corneci D, Negoita SI, Bilotta F. Iatrogenic withdrawal syndrome in adult intensive care unit: a scoping review. Front Med (Lausanne). 2025 Jul 23;12:1573363. doi: 10.3389/fmed.2025.1573363. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This is an International Delphi Consensus on the Definition and Diagnosis of Iatrogenic Withdrawal Syndrome in adult critically ill patients. It involves the anonymous completion of a questionnaire using a 7-point Likert scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Professionals from the following medical specialties are eligible: Intensive Care Medicine, Anesthesiology or Psychiatry.\n\nParticipants to this Delphi Consensus must have at least 5 years of experience in their field.\n\nAcademic title or previous research published in the field of Iatrogenic Withdrawal Syndrome are not mandatory.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 5 years of experience or training or research in the field of Intensive Care Medicine, Anesthesiology or Psychiatry\n\nExclusion Criteria:\n\n* Not a specialist in the fields of Intensive Care Medicine, Anesthesiology or Psychiatry'}, 'identificationModule': {'nctId': 'NCT07316894', 'briefTitle': 'IWS Diagnosis Criteria Consensus', 'organization': {'class': 'OTHER', 'fullName': 'ELIAS Emergency University Hospital'}, 'officialTitle': 'International Delphi Consensus on the Universal Definition and Diagnosis of Iatrogenic Withdrawal Syndrome in Adult ICU Patients', 'orgStudyIdInfo': {'id': '10122025'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ICU, Anesthesiology and Psychiatry specialists consensus on the diagnosis of IWS.', 'type': 'OTHER', 'description': 'This is a new and originally developed questionnaire comprising of 19 questions. Out of 19 questions, 17 use a 7-point Likert scale response, one uses a Yes/No type of answer and one has open answers.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '011461', 'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC', 'role': 'CONTACT', 'email': 'emanuel.moisa@umfcd.ro', 'phone': '+40753021128'}, {'name': 'Georgeana Tuculeanu, Assist. Prof., MD', 'role': 'CONTACT', 'email': 'georgeana.tuculeanu@gmail.com', 'phone': '+40751141239'}, {'name': 'Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Elias Emergency University Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'centralContacts': [{'name': 'Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC', 'role': 'CONTACT', 'email': 'emanuel.moisa@umfcd.ro', 'phone': '+40753021128'}, {'name': 'Jamel Ortoleva, Assoc. Prof, MD, FASE', 'role': 'CONTACT', 'phone': '812-272-7078'}], 'overallOfficials': [{'name': 'Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elias Emergency University Hospital of Bucharest, Carol Davila University of Medicine and Pharmacy, Bucharest'}, {'name': 'Federico Bilotta, Professor, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tor Vergata University of Rome'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'The exact number of answers provided for each question from the questionnaire will be provided, as well as all the Delphi rounds in which agreement was or was not met.\n\nDemographic data about experts in order to ensure their eligibility.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ELIAS Emergency University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, {'name': 'Boston University', 'class': 'OTHER'}, {'name': 'Carol Davila University of Medicine and Pharmacy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, DESAIC, Assistant Professor and Specialist of Anaesthesia and Critical Care Medicine,', 'investigatorFullName': 'Emanuel Moisa', 'investigatorAffiliation': 'ELIAS Emergency University Hospital'}}}}