Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT01973894
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2012-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Midazolam Whole Body Physiologically Based Pharmacokinetic Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D003128', 'term': 'Coma'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2012-08-19', 'studyFirstSubmitQcDate': '2013-10-25', 'lastUpdatePostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Midazolam concentration in serum and urine', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 3 weeks', 'description': 'We will calculate Midazolam AUC in serum and urine using blood and urine samples. With this data we will evaluate the elimination constants and create a Physiologically Based Pharmacokinetic Model for Midazolam simulating the drug concentration profile in brain and fat tissue.\n\nThe blood and urine samples timing is:\n\n* 1 blood sample will be gathered after 24h at the beginning of continuous intravenous infusion of Midazolam\n* 1 blood sample and 1 urine sample will be gathered after 48h at the beginning of continuous intravenous infusion of Midazolam\n* 1 blood sample will be gathered at the end of continuous intravenous infusion of Midazolam (the duration of infusion is different for each patient according with clinical case)\n* 1 blood sample and 1 urine sample will be gathered after 6h at the end of continuous intravenous infusion of Midazolam (the duration of infusion is different for each patient according with clinical case)'}], 'secondaryOutcomes': [{'measure': 'Fat mass analysis and its importance in drug distribution.', 'timeFrame': 'At enrollment', 'description': 'At enrollment we will collect data about fat mass in our population. Our goal is to determine how much this variable can modify the distribution of Midazolam in the body. Statistical analysis will performed to found if different body mass values are correlated with different blood concentration of Midazolam at steady level.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PBPK', 'Midazolam', 'Pharmacokinetics', 'Critically ill patients'], 'conditions': ['Respiratory Failure', 'Coma']}, 'descriptionModule': {'briefSummary': 'This study investigates what independent variables may influence Midazolam Pharmacokinetics in critically ill patients.', 'detailedDescription': 'This study has three specific aims:\n\n1. to create a Midazolam PBPK model based on anthropometric and physiopathological data from enrolled patients;\n2. to estimate cerebral and systemic Midazolam concentrations;\n3. to assess independent variables about Midazolam pharmacokinetic in critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients in Intensive Care Unit, mechanically ventilated, sedated with midazolam, intravenous continued perfusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU admittance\n* Caucasian\n* Clinical indication of least 72h of continuous sedation with Midazolam\n* MAP between 60 - 150 mmHg, even if obtained with amine support\n* informed consent obtained\n\nExclusion Criteria:\n\n* Any endocranial lesion, spontaneous or induced\n* PaCO2 \\> 60 mmHg or \\< 30 mmHg\n* PaO2 \\< 50 mmHg\n* Pregnancy\n* Anuria\n* Any transplantation\n* Severe hepatic failure (Child C)\n* Life expectancy \\< 72h\n* Ketoconazole and antiretrovirals in therapy'}, 'identificationModule': {'nctId': 'NCT01973894', 'acronym': 'MidPBPK', 'briefTitle': 'Midazolam Whole Body Physiologically Based Pharmacokinetic Model', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Whole Body Physiologically Based Pharmacokinetic (PBPK) Model to Estimate Cerebral and Systemic Midazolam Concentrations in ICU Patients Under Sedation.', 'orgStudyIdInfo': {'id': '724'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Midazolam', 'description': 'Patients will be enrolled within 24h from the beginning of continuous Midazolam perfusion.\n\nBlood and urine sampling will follow this schedule:\n\n* 24h: blood (3ml)\n* 48h: blood (3ml) and urine\n* End of infusion: blood (3ml)\n* 6h after end of infusion: blood (3ml) and urine.\n\nBlood samples will be centrifuged for 10 minutes at 3300rpm, then supernatant will be placed into test tubes and stored at -20°C; urine samples will be freeze at -20°C as well.\n\nThen all frozen samples will be analyzed to get Midazolam concentrations.', 'interventionNames': ['Procedure: Blood and urine sampling']}], 'interventions': [{'name': 'Blood and urine sampling', 'type': 'PROCEDURE', 'description': 'Blood and urine sampling will follow this schedule:\n\n* 24h: blood (3ml)\n* 48h: blood (3ml) and urine\n* End of infusion: blood (3ml)\n* 6h after end of infusion: blood (3ml) and urine. Blood samples will be centrifuged for 10 minutes at 3300rpm, then supernatant will be placed into test tubes and stored at -20°C; urine samples will be freeze at -20°C as well.\n\nThen all frozen samples will be analyzed to get Midazolam concentrations.', 'armGroupLabels': ['Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'overallOfficials': [{'name': 'Paolo Severgnini, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Insubria, Varese, Italy"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Milan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Paolo Severgnini', 'investigatorAffiliation': "Università degli Studi dell'Insubria"}}}}