Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 7:05 AM
Study NCT ID:
NCT04920734
Status:
TERMINATED
Last Update Posted:
2025-02-24
First Post:
2021-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - CESARO II
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lack of equipment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient-specific characteristics', 'timeFrame': 'At the beginning of the investigation', 'description': 'Patient-specific characteristics are measured by demographic data'}], 'primaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'Up to three months', 'description': 'Postoperative complications according to Clavien-Dindo classification'}], 'secondaryOutcomes': [{'measure': 'Duration of delirium', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Duration of delirium is measured in days'}, {'measure': 'Incidence of delirium', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) and/or as ≥ 2 cumulative points in the Nursing Delirium Screening Scale (Nu-DESC) and/or a positive Confusion Assessment Method (CAM) and/or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score and/or patient chart review that shows descriptions of delirium.'}, {'measure': 'Preventive measures against delirium 1', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Preventive measures of delirium are measured by medical treatments'}, {'measure': 'Preventive measures against delirium 2', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Preventive measures of delirium are measured by non-medical treatments'}, {'measure': 'Anticholinergic drugs', 'timeFrame': 'Time until discharge from hospital, an expected average of 7 days', 'description': 'Measured by anticholinergic drug scale'}, {'measure': 'Treatment of delirium', 'timeFrame': 'Time until discharge from hospital, an expected average of 7 days', 'description': 'Treatment of delirium with medication'}, {'measure': 'Measurement of acetylcholinesterase', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Measurement of activities of the enzyme - acetylcholinesterase in blood'}, {'measure': 'Measurement of butyrylcholinesterase', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Measurement of activities of the enzyme - butyrylcholinesterase in blood'}, {'measure': 'Chronic comorbid diseases', 'timeFrame': 'Time until discharge from hospital, an expected average of 7 days', 'description': 'Chronic comorbid diseases (comorbidities) are measured by Charlson comorbidity index'}, {'measure': 'Health related quality of life', 'timeFrame': 'Up to three months', 'description': 'EQ-5D'}, {'measure': 'Treatment of vegetative symptoms', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Treatment of vegetative symptoms is measured by vegetative medical therapy'}, {'measure': 'Treatment of pain', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Treatment of pain is measured by analgesia'}, {'measure': 'Treatment of postoperative vomiting', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Treatment of postoperative vomiting is measured by anti-emetics'}, {'measure': 'Treatment of productive psychotic symptoms', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Treatment of productive psychotic symptoms is measured by anti-psychotics'}, {'measure': 'Treatment of anxiety', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Treatment of anxiety is measured by anxiolytics'}, {'measure': 'Treatment of sleep disorders', 'timeFrame': 'Time until discharge from recovery room, an expected average of 5 days', 'description': 'Treatment of sleep disorders are measured by sleeping drugs'}, {'measure': 'Number of participants with changes in laboratory values', 'timeFrame': 'Time until discharge from hospital, an expected average of 7 days', 'description': 'Routine laboratory results were planned to be documented in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count from blood samples.'}, {'measure': 'Apache II', 'timeFrame': 'Time until discharge from intensive care unit, an expected average of 6 days', 'description': 'APACHE II score is measured by the Acute Physiology and Chronic Health Evaluation System II.'}, {'measure': 'SOFA', 'timeFrame': 'Time until discharge from intensive care unit, an expected average of 6 days', 'description': 'SOFA is measured by Sequential Organ Failure Assessment.'}, {'measure': 'SAPS II', 'timeFrame': 'Time until discharge from intensive care unit, an expected average of 6 days', 'description': 'SAPS II is measured by Simplified Acute Physiology Score II.'}, {'measure': 'Intensive care unit stay', 'timeFrame': 'Time until discharge from intensive care unit, an expected average of 6 days', 'description': 'Intensive care unit stay is measured in days'}, {'measure': 'Hospital stay', 'timeFrame': 'Time until discharge from hospital, an expected average of 7 days', 'description': 'Hospital stay is measured in days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium']}, 'descriptionModule': {'briefSummary': 'This project is a multicenter pilot project to evaluate the therapeutic success in the long term up to 3 months after a delirium in a recovery room. There is a Europe-wide recommendation for the prevention of postoperative delirium in older patients and the evidence and consensus-based guideline "Management of delirium, analgesia and sedation in intensiv care medicine" of the AWMF (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften) are regularly updated for the detection and treatment of delirium in the intensive care unit. The aim is to evaluate the effects of a systematic delirium screening and the delirium treatment options in the long term in the same way as the current recommendations for the patient cohort of the recovery room.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to the recovery room who have been diagnosed with delirium', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted to the recovery room who have been diagnosed with delirium according to the treating physicians\n* The patient is on a ward in the hospital\n* Age ≥ 18 years\n* Stay in the recovery room ≥ 1 day\n* The patient is able to give consent\n\nExclusion Criteria:\n\n* Participation in a prospective intervention study (except adjuvant therapy study)\n* Patients with underlying neurological diseases that make it difficult to differentiate from delirium\n* Missing contact 3 months after stay in the recovery room.'}, 'identificationModule': {'nctId': 'NCT04920734', 'briefTitle': 'Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - CESARO II', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Description of Therapy Options and Successes in the Long-term Course of Delirium in the Recovery Room - Multicenter Observational Study (CESARO-2)', 'orgStudyIdInfo': {'id': 'CESARO-2'}}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.- Prof. Dr. C. Spies', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}