Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 10:34 PM
Study NCT ID:
NCT04218461
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2019-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREdiction of DELIRium in Medical ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2019-12-30', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predict of delirium risk with questionnare', 'timeFrame': 'up to 20 weeks', 'description': "CAM-ICU will be used for defining the delirium risk. We define delirium as a minimum of one positive CAM-ICU screening during each patient's intensive care stay developed and validated for ICU patients, assesses 10 risk factors for delirium that are readily observable within the first 24 hours following ICU admission. CAM-ICU scale includes of four items. The items are about level of consciousness, assessment of attention, state of thought organization and following a simple command. In order to be diagnosed with delirium, the first two items and one of the third or fourth item must be in favor of delirium."}, {'measure': 'Predict of delirium risk with questionnare 2', 'timeFrame': 'up to 20 weeks', 'description': 'The PRE-DELIRIC model will be used for defining the delirium risk. The PRE-DELIRIC model developed and validated for ICU patients, assesses 10 risk factors for delirium that are readily observable within the first 24 hours following ICU admission. The model consists of biochemical parameters, used drugs, infection status.'}, {'measure': 'Comparison of delirium risk with two questionnares', 'timeFrame': 'up to 20 weeks', 'description': 'The investigator will assess the CAM-ICU and PRE-DELIRIC in the first 24 hours after the patient comes to the ICU. The PRE-DELIRIC model and CAM-ICU will use for defining the deliirum risk. The investigators will do validity and reliability of PRE-DELIRIC model in medical ICU patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium', 'Intensive Care Unit Delirium']}, 'referencesModule': {'references': [{'pmid': '22323509', 'type': 'BACKGROUND', 'citation': 'van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.'}, {'pmid': '29742219', 'type': 'BACKGROUND', 'citation': 'Sosa FA, Roberti J, Franco MT, Kleinert MM, Patron AR, Osatnik J. Assessment of delirium using the PRE-DELIRIC model in an intensive care unit in Argentina. Rev Bras Ter Intensiva. 2018 Mar;30(1):50-56. doi: 10.5935/0103-507x.20180010.'}, {'pmid': '30507844', 'type': 'BACKGROUND', 'citation': 'Green C, Bonavia W, Toh C, Tiruvoipati R. Prediction of ICU Delirium: Validation of Current Delirium Predictive Models in Routine Clinical Practice. Crit Care Med. 2019 Mar;47(3):428-435. doi: 10.1097/CCM.0000000000003577.'}]}, 'descriptionModule': {'briefSummary': 'In intensive care unit (ICU) patients, the ability to predict delirium may help reduce its incidence, duration, and severity. The PREdiction of DELIRium in ICU (PRE-DELIRIC) model was recently developed for this purpose. Our aim was to test the PRE-DELIRIC model in the medical ICU.', 'detailedDescription': 'Delirium, a disturbance of consciousness with an acute onset and a variable course of impaired cognitive functioning, is common in patients admitted to the ICU. Several tools are available for assessing delirium in ICU patients, of which the confusion assessment method-intensive care unit (CAM-ICU) has the highest sensitivity and specificity.\n\nAlthough several predictive models for non-intensive care patients exist, as well as one for older medical intensive care patients, no evidence based prediction model for general intensive care patients is available. Also the tools are not involved the metabolic parameters which cause delirium. Because of that the tool need to have biochemical parameters.\n\nIn the light of these information our aim is to validate the PRE-DELIRIC model in medical ICU in Turkish people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stay in the medical ICU', 'eligibilityCriteria': "Inclusion Criteria:\n\n* be at the medical ICU\n* 18 and older years of age\n* predict to stay in the ICU over 24 hours\n* not to be pregnant\n* not to be breastfeeding\n* not to have dementia, alcoholism\n* have not previously received a diagnosis of delirium\n* have not communication problem\n* agree to participate to the study by patient's relatives\n\nExclusion Criteria:\n\n* younger than 18 years old\n* stay in the ICU less than 24 hours\n* be pregnant\n* breastfeeding\n* have dementia, alcoholism\n* previously received a diagnosis of delirium\n* have communication problem\n* not agree to participate to the study by patient's relatives"}, 'identificationModule': {'nctId': 'NCT04218461', 'briefTitle': 'PREdiction of DELIRium in Medical ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Demiroglu Bilim University'}, 'officialTitle': 'Evaluation of the Usability of the Delirium Prediction Model of PRE-DELIRIC (PREdiction of DELIRium) in Medical ICU Patients', 'orgStudyIdInfo': {'id': '2019-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PRE-DELIRIC model', 'type': 'DIAGNOSTIC_TEST', 'description': 'To predict delirium according to risk factors in the PRE-DELIRIC model'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34360', 'city': 'Istanbul', 'state': 'Sisli', 'country': 'Turkey (Türkiye)', 'facility': 'Demiroglu Bİlim University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Nurten OZEN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Demiroglu Bilim University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Demiroglu Bilim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nurten Ozen', 'investigatorAffiliation': 'Istanbul Demiroglu Bilim University'}}}}