Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT05555667
Status:
UNKNOWN
Last Update Posted:
2023-05-26
First Post:
2022-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Sedation With Remimazolam Besylate in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 728}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of time in the target sedation range without rescue sedation', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'The percentage of time in the target sedation range without rescue sedation'}], 'secondaryOutcomes': [{'measure': 'Invasive ventilator free time', 'timeFrame': 'From start of study to 7 days', 'description': 'Hours of time free from invasive ventilator'}, {'measure': 'Successful extubation rate', 'timeFrame': 'From start of study to 7 days', 'description': 'Extubation of endotracheal tube for the first time in 7 days without reintubation or switching to tracheostomy within the following 48 hours'}, {'measure': 'Length of ICU stay', 'timeFrame': 'From start of study to 28 days', 'description': 'Length of ICU stay'}, {'measure': 'Mortality', 'timeFrame': 'From start of study to 28 days', 'description': 'Mortality'}, {'measure': 'Length of hospitalization', 'timeFrame': 'From start of study to 28 days', 'description': 'Length of hospitalization'}, {'measure': 'weaning time', 'timeFrame': 'From start of study to 7 days', 'description': 'weaning time in minutes between continuous discontinuation of the study drug and extubation in patients with successful extubation'}, {'measure': 'Rate of hypotension', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'Systolic blood pressure less than 80 mmHg or diastolic blood pressure less than 50 mmHg for 5 minutes or treated with vasopressors'}, {'measure': 'Rate of hypertension', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mmHg for 5 minutes or treated with vasodilators'}, {'measure': 'Rate of bradycardia', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'heart rate less than 50 bpm for 5 minutes or treated with medication to increase heart rate'}, {'measure': 'Rate of tachycardia', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'heart rate greater than 120 bpm for 5 minutes or treated with medication to decrease heart rate'}, {'measure': 'Rate of unplanned extubation of endotracheal tube', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'unplanned extubation of endotracheal tube'}, {'measure': 'Rate of shock', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'New-onset shock'}, {'measure': 'Rate of hospital-acquired pneumonia', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'hospital-acquired pneumonia'}, {'measure': 'Rate of myocardial infarction', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'myocardial infarction'}, {'measure': 'Rate of cerebral ischemic stroke', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'cerebral ischemic stroke'}, {'measure': 'Rate of cerebral hemorrhagic stroke', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'Rate of cerebral hemorrhagic stroke'}, {'measure': 'Rate of pulmonary embolism', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'pulmonary embolism'}, {'measure': 'Rate of upper digestive tract ulcer confirmed endoscopically', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'upper digestive tract ulcer confirmed endoscopically'}, {'measure': 'Rate of more than 500 milliliters of bloody stool', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'more than 500 milliliters of bloody stool'}, {'measure': 'Rate of delirium', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'delirium'}, {'measure': 'delta SOFA', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'defined as the difference between SOFA when each patient stops receiving the study drug and SOFA at inclusion'}, {'measure': 'Rate of withdraw from the trial because of intolerance, severe adverse events or other safety concerns', 'timeFrame': '7 days after enrollment, or when patients decease, require deep sedation, are scheduled for surgery, are discontinued from the study drug for at least 12 hours, are discharged from ICU, or are withdrawn from the trial, whichever comes first', 'description': 'rate of withdraw from the trial because of intolerance, severe adverse events or other safety concerns'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Light Sedation', 'Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '37576823', 'type': 'DERIVED', 'citation': 'Yang X, Tang Y, Du R, Yu Y, Xu J, Zhang J, Liu H, Zou X, Ren L, Yuan S, Shang Y. Long-term sedation with remimazolam besylate versus propofol in critically ill patients during invasive mechanical ventilation: a study protocol for a multicenter randomized non-inferior trial. Front Pharmacol. 2023 Jul 28;14:1139872. doi: 10.3389/fphar.2023.1139872. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'A randomized non-inferior trial comparing remimazolam besylate with propofol for long-term sedation during invasive mechanical ventilation in critically ill patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 80 years;\n* Intubated and mechanically ventilated ≤96 hours before enrollment；\n* Expected to require continuous invasive ventilation and sedation ≥24 hours;\n* Requirement for light to moderate sedation (a RASS score of -3 to 0)\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\<18 or \\>30 kg/m2;\n* Allergy or unsuitabilty to any composition of study drugs or remifentanil;\n* Living expectancy less than 48 hours；\n* Possible surgey in the operating room in 24 hours；\n* Myasthenia gravis;\n* Serious hepatic dysfunction (CTP 10-15);\n* Chronic kidney disease with glomerular filtration rate (GFR) \\< 29 ml/min/1.73m2;\n* Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;\n* Acute severe neurological disorder and any other condition interfering with RASS assessment;\n* Pregnancy or lactation;\n* Unstable angina or acute myocardial infarction;\n* Left ventricular ejection fraction less than 30%;\n* Heart rate less than 50 beats/min;\n* Grade 2 , second degree or third degree atrioventricular block in the absence of a pacemaker;\n* Abuse of controlled substances or alcohol;\n* Other conditions deemed unsuitable to be included;'}, 'identificationModule': {'nctId': 'NCT05555667', 'acronym': 'LOSREB', 'briefTitle': 'Long-term Sedation With Remimazolam Besylate in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Long-term Sedation With Remimazolam Besylate Versus Propofol in Critically Ill Patients During Invasive Mechanical Ventilation: a Randomized Non-inferior Trial', 'orgStudyIdInfo': {'id': 'WHUICU202209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam besylate', 'description': 'Remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted (maximum of 0.3 mg/kg/h) to maintain a RASS score between - 3 and 0', 'interventionNames': ['Drug: Remimazolam besylate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Propofol intravenously at an initial infusion rate of 2.0 mg/kg/h and adjusted (maximum of 4.0 mg/kg/h) to maintain a RASS score between - 3 and 0', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Remimazolam besylate', 'type': 'DRUG', 'description': 'Sedation drug', 'armGroupLabels': ['Remimazolam besylate']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol. Sedation drug', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaobo Yang', 'role': 'CONTACT'}], 'facility': 'Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'You Shang, MD', 'role': 'CONTACT', 'email': 'you_shanghust@163.com', 'phone': '008602785726114', 'phoneExt': '61606'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xiaobo Yang, MD', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}