Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-27 @ 9:42 AM
Study NCT ID:
NCT02216266
Status:
UNKNOWN
Last Update Posted:
2017-03-10
First Post:
2013-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation if Physostigmine Reduces Symptoms in Patients Who Has Developed a Delirium in Intensive Care After a Surgery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010830', 'term': 'Physostigmine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D048448', 'term': 'Phenylcarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2013-10-17', 'studyFirstSubmitQcDate': '2014-08-11', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS)', 'timeFrame': 'baseline to 48 hours after administration'}], 'secondaryOutcomes': [{'measure': 'reduction of weaning time at mechanical ventilator of patients with symptoms of delirium', 'timeFrame': 'baseline to 48 hours after administration'}, {'measure': 'change in the spontaneous EEG and auditory evoked potentials', 'timeFrame': 'baseline to 48 hours after administration', 'description': 'for the spontaneous EEG, we expect a shift in the frequency characteristics, measure is the spectrogram, more precisely the amplitude per frequency (band) and the phase information derived via Fourier Transform and Wavelet transformation\n\nThe paradigm of the auditory stimulation is a roving paradigm (Science 13 May 2011:\n\nVol. 332 no. 6031 pp. 858-862 DOI: 10.1126/science.1202043\n\n•Report Preserved Feedforward But Impaired Top-Down Processes in the Vegetative State Melanie Boly1,2,\\*, Marta Isabel Garrido2, Olivia Gosseries1, Marie-Aurélie Bruno1, Pierre Boveroux3, Caroline Schnakers1, Marcello Massimini4, Vladimir Litvak2, Steven Laureys1, Karl Friston2) Measures will be differences in the mismatch negativity and in the phase synchronization between electrodes'}, {'measure': 'impact of the variability of heart rate', 'timeFrame': 'baseline to 48 hours', 'description': 'heart rate variability is a dimensionless parameter, assessing the variability of the heart rate from ECG measures (Heart Rate Variability Conny M. A. van Ravenswaaij-Arts, MD; Louis A. A. Kollee, MD, PhD; Jeroen C. W. Hopman, MSc; Gerard B. A. Stoelinga, MD, PhD; and Herman P. van Geijn, MD, PhD \\[+-\\] Article and Author Information\n\nAnn Intern Med. 1993;118(6):436-447. doi:10.7326/0003-4819-118-6-199303150-00008 )'}, {'measure': 'change in development of muscular force', 'timeFrame': 'baseline up to 48 hours', 'description': 'muscular force is measured with a force gauge, measured in \\[Newton\\]'}, {'measure': 'Occurence of Adverse events', 'timeFrame': 'baseline to 4 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Delirium', 'CAM-ICU'], 'conditions': ['Suspected Delirium After Elective or Emergency Heart Surgery', 'CAM-ICU Diagnosed Delirium']}, 'descriptionModule': {'briefSummary': 'Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both genders aged \\> 18 years, \\< 85 years of ICU C1 after elective or emergency heart surgery with or without extracorporeal circulation (heart-lung machine and/or extracorporeal membrane oxygenation), with suspected delirium. (May be suspected if a patient does not show adequate improvement of vigilance 24 h after adequate reduction or stop of sedative medicine)\n* Patients (\\>18a, \\<85a) with CAM-ICU diagnosed delirium\n* Patients of legal capacity and patients with appointed representative\n\nExclusion Criteria:\n\n* Asthma\n* hypersensitivity against Physostigmine salicylate, Sodium metabisulfite, Nitrogen\n* gangrene mechanical obstipation\n* mechanical urinary retention\n* Dystrophia myotonica\n* Depolarization block after depolarising muscle relaxants\n* Intoxications with "irreversibly acting" cholinesterase inhibitors\n* closed head trauma\n* obstructions at gastro-intestinal tract and at urinary tract\n* neurological diseases\n* left ventricular ejection fraction \\< 40%\n* Simultaneous Participation in other clinical trials or participation ind other clinical trials in the last 30 days\n* untreated coronary heart disease\n* wish to have children, pregnancy or nursing\n* patients with addictive disorder in medical history'}, 'identificationModule': {'nctId': 'NCT02216266', 'briefTitle': 'Evaluation if Physostigmine Reduces Symptoms in Patients Who Has Developed a Delirium in Intensive Care After a Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Monocenter, Double Blind, Randomised, Placebo Controlled Study to Evaluate Physostigmine for the Treatment of Delirium in Perioperative Intensive Care Medicine', 'orgStudyIdInfo': {'id': 'DELIcu'}, 'secondaryIdInfos': [{'id': '2012-004082-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physostigmine', 'description': 'Physostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram', 'interventionNames': ['Drug: Physostigmine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium Chloride solution', 'description': 'solution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram', 'interventionNames': ['Other: Sodium Chloride solution']}], 'interventions': [{'name': 'Physostigmine', 'type': 'DRUG', 'otherNames': ['Anticholium'], 'armGroupLabels': ['Physostigmine']}, {'name': 'Sodium Chloride solution', 'type': 'OTHER', 'otherNames': ['NaCl solution as Placebo comparator'], 'armGroupLabels': ['Sodium Chloride solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt', 'state': 'Hessia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bertram Scheller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}], 'centralContacts': [{'name': 'Bertram Scheller, MD', 'role': 'CONTACT', 'email': 'bertram.scheller@kgu.de'}], 'overallOfficials': [{'name': 'Bertram Scheller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy of Goethe-University Frankfurt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PD Dr. Bertram Scheller', 'class': 'OTHER'}, 'collaborators': [{'name': 'Goethe University', 'class': 'OTHER'}, {'name': 'Dr. Franz Köhler Chemie GmbH (study medication and labeling)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PD MD Bertram Scheller', 'investigatorFullName': 'PD Dr. Bertram Scheller', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}