Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-01 @ 8:59 AM
Study NCT ID:
NCT06727903
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Model for Mortality in Older People With Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'Day 90', 'description': 'mortality on day 90 from admission to Intensive Care Unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical Illness', 'Mortality', 'Aged', 'Intensive Care Units'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'The present study aims to develop a predictive model to identify elderly patients with the highest likelihood of mortality upon admission to an intensive care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to a Intensive Care Unit', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged 75 or older.\n* Admission to an ICU from the Emergency Department.\n* Availability of or possibility to contact a participant's informant.\n* Informed consent for participation in the study, either by the participant or a valid legal representative.\n\nExclusion Criteria:\n\nParticipants meeting any of the following exclusion criteria will not be included in the study:\n\n* Patients transferred to the Emergency Department from a hospital ward.\n* Patients who die within the first 24 hours of ICU admission.\n* Patients admitted to Step-Down Units.\n* Patients requiring ICU admission for any of the following reasons:\n\nOrotracheal intubation or advanced cardiopulmonary resuscitation performed prior to arrival at the Emergency Department.\n\nAV block awaiting pacemaker implantation. Activation of the STEMI or Stroke care pathway. Post-cardiac catheterization for acute coronary syndrome.\n\n* Participation in another clinical study involving an intervention, procedure, or visit schedule that is incompatible with the present study."}, 'identificationModule': {'nctId': 'NCT06727903', 'acronym': 'VITA', 'briefTitle': 'Predictive Model for Mortality in Older People With Critical Illness', 'organization': {'class': 'OTHER', 'fullName': "Consorci Sanitari de l'Alt Penedès i Garraf"}, 'officialTitle': 'Development of a Predictive Model for Mortality in Patients Aged 75 or Older With Critical Illness', 'orgStudyIdInfo': {'id': 'CSAPG-66'}}, 'armsInterventionsModule': {'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Results of laboratory biomarker analysis will be analyzed as predictors for mortality'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Clarissa Catalano, MD', 'role': 'CONTACT', 'email': 'ccatalanonada@gmail.com', 'phone': '0034934651200'}, {'name': 'Regina Roig, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital German Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08810', 'city': 'Sant Pere de Ribes', 'state': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando Gerber', 'role': 'CONTACT', 'email': 'jfgerber@csapg.cat', 'phone': '0034938960025'}, {'name': 'Noemí Casaponsa', 'role': 'CONTACT', 'email': 'recerca@csapg.cat', 'phone': '0034938960025', 'phoneExt': '43197'}, {'name': 'Fernando Gerber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Consorci Sanitari Alt Penedès-Garraf', 'geoPoint': {'lat': 41.26045, 'lon': 1.77391}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pedro Castro', 'role': 'CONTACT', 'email': 'pcastro@clinic.cat', 'phone': '0034932 27 54 00'}, {'name': 'Pedro Castro', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Karla Núñez', 'role': 'CONTACT', 'email': 'kanuvaz@gmail.com', 'phone': '0034932 54 24 00'}, {'name': 'Karla Núñez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carles Subirà', 'role': 'CONTACT', 'email': 'CSubira@santpau.cat', 'phone': '0034932 91 90 00'}, {'name': 'Carles Subirà', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Estel Güell', 'role': 'CONTACT', 'email': 'eguell@csdm.cat', 'phone': '0034937 41 77 00'}, {'name': 'Estel Güell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Mataró', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Manuel Buitrago', 'role': 'CONTACT', 'email': 'MBuitrago@CST.CAT', 'phone': '0034937 31 00 07'}, {'name': 'Manuel Buitrago', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Terrassa', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Zapatero', 'role': 'CONTACT', 'email': 'azapatero@psmar.cat', 'phone': '0034932 48 30 00'}, {'name': 'Ana Zapatero', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Elida Amestoy', 'role': 'CONTACT', 'email': 'elida.amestoy@quironsalud.es', 'phone': '0034 932 27 47 47'}, {'name': 'Elida Amestoy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Dexeus Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'María Dolores Bosque', 'role': 'CONTACT', 'email': 'mdbosque@quironsalud.es', 'phone': '0034900 301 013'}, {'name': 'María Dolores Bosque', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General de Catalunya', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Zaira Chova', 'role': 'CONTACT', 'email': 'zaira_gandia@hotmail.com', 'phone': '0034938 42 50 00'}, {'name': 'Zaira Chova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General de Granollers', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Omar Correa', 'role': 'CONTACT', 'email': 'omar.correa@quironsalud.es', 'phone': '0034933 22 11 11'}, {'name': 'Omar Correa', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Sagrat Cor', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Girona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mariano Rinaudo', 'role': 'CONTACT', 'email': 'marianorinaudo@gmail.com', 'phone': '0034972204500'}, {'name': 'Mariano Rinaudo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica Girona', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Girona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Malena Tejada', 'role': 'CONTACT', 'email': 'malenactejada@gmail.com', 'phone': '0034972 18 26 00'}, {'name': 'Malena Tejada', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Santa Caterina', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Girona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jordi Parisi', 'role': 'CONTACT', 'email': 'jparisi.girona.ics@gencat.cat', 'phone': '0034 972 940 200'}, {'name': 'Jordi Parisi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitari Dr. Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}], 'centralContacts': [{'name': 'César Gálvez, Ph.D.', 'role': 'CONTACT', 'email': 'cgalvez@csapg.cat', 'phone': '+34 9389600325'}, {'name': 'Noemí Casaponsa', 'role': 'CONTACT', 'email': 'recerca@csapg.cat', 'phone': '+34 938960025', 'phoneExt': '43197'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After publication of main results of the study.', 'ipdSharing': 'YES', 'description': 'IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).', 'accessCriteria': 'IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Consorci Sanitari de l'Alt Penedès i Garraf", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}