Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 1:54 PM
Study NCT ID:
NCT07007156
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is a Positive NECPAL in ICU Patients Associated With Higher Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000208', 'term': 'Acute Disease'}], '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': 199}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'From baseline to 90-day', 'description': 'Patients who dye at 90-day from ICU admission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Disease', 'Intensive Care Unit'], 'conditions': ['Acute Disease']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the usefulness of the NECPAL scale in identifying Intensive Care Unit (ICU)-admitted patients at higher risk of dying within 90 days of ICU admission'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 75 years or older who are admitted to an ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who meet all of the following inclusion criteria may be included in the study:\n* Men and women aged 75 years or older.\n* Admission to the ICU of the study center.\n* Legal capacity to provide informed consent.\n* Signed informed consent for study inclusion, either by the participant or their legal representative.\n\nExclusion Criteria:\n\nParticipants who meet any of the following exclusion criteria may not be included in the study:\n\n-Death within the first 24 hours of ICU admission.'}, 'identificationModule': {'nctId': 'NCT07007156', 'briefTitle': 'Is a Positive NECPAL in ICU Patients Associated With Higher Mortality', 'organization': {'class': 'OTHER', 'fullName': "Consorci Sanitari de l'Alt Penedès i Garraf"}, 'officialTitle': 'Is a Positive NECPAL in ICU Patients Associated With Higher Mortality', 'orgStudyIdInfo': {'id': 'CSAPG-74'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NECPAL positive', 'type': 'OTHER', 'description': 'This group has a positive result for NECPAL scale'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08800', 'city': 'Sant Pere de Ribes', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Diana Gutiérrez, MD', 'role': 'CONTACT', 'email': 'dpgutierrez@csapg.cat', 'phone': '+34 938960025'}, {'name': 'Noemí Casaponsa', 'role': 'CONTACT', 'email': 'recerca@csapg.cat', 'phone': '+34 938960025', 'phoneExt': '43197'}, {'name': 'Diana Gutiérrez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CSAPG', 'geoPoint': {'lat': 41.26045, 'lon': 1.77391}}], 'centralContacts': [{'name': 'Diana Gutiérrez, MD', 'role': 'CONTACT', 'email': 'dpgutierrez@csapg.cat', 'phone': '+34938960025'}, {'name': 'Noemí Casaponsa', 'role': 'CONTACT', 'email': 'recerca@csapg.cat', 'phone': '+34 938960025', 'phoneExt': '43197'}], 'overallOfficials': [{'name': 'Diana Gutiérrez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSAPG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Consorci Sanitari de l'Alt Penedès i Garraf", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}