Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT05782894
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2023-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077208', 'term': 'Remifentanil'}], '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'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2023-02-18', 'studyFirstSubmitQcDate': '2023-03-12', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hypotension', 'timeFrame': '24 hours', 'description': 'Whether hypotension occurs in participants'}, {'measure': 'Delirium', 'timeFrame': '24 hours', 'description': 'Whether delirium occurs in participants'}], 'primaryOutcomes': [{'measure': 'Successful sedation', 'timeFrame': '24 hours', 'description': '70% of time in the target sedation range in participants without rescue sedation'}], 'secondaryOutcomes': [{'measure': 'The percentage of time in the target sedation range without rescue sedation', 'timeFrame': '24 hours', 'description': 'The percentage of time in the target sedation range without rescue sedation'}, {'measure': 'Number of patients needing rescue sedation', 'timeFrame': '24 hours', 'description': 'Whether participants need sedative drugs other than the study drug to re maintain targeted sedation level'}, {'measure': 'Number of patients needing repeated boluses of the study drug', 'timeFrame': '24 hours', 'description': 'Whether participants need repeated boluses of the study durg other than the loading dose to maintain targeted sedation level'}, {'measure': 'The amount of remifentanil in ug/kg/h', 'timeFrame': '24 hours', 'description': 'The amount of remifentanil in ug/kg/h used in each patient in both groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedative', 'Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '40493335', 'type': 'DERIVED', 'citation': 'Tang Y, Shu H, Ren L, Li R, Zou X, Qi H, Ouyang Y, Wu Y, Xu J, Fang X, Yang X, Shang Y. Remimazolam Besylate Versus Propofol for Short-Term Sedation in Critically Ill Patients Receiving Mechanical Ventilation: Protocol for a Multicenter Randomized Non-inferior Trial. Adv Ther. 2025 Aug;42(8):4081-4088. doi: 10.1007/s12325-025-03268-7. Epub 2025 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units'}, '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* Body mass index (BMI) ≥18 and ≤ 30 kg/m2\n* Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on ventilator for at least 6 hours\n* Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)\n\nExclusion Criteria:\n\n* Refusal to be included\n* Allergy or unsuitability to any composition of study drugs or remifentanil\n* Living expectancy less than 48 hours\n* Myasthenia gravis\n* Status asthmaticus\n* Abdominal compartment syndrome\n* Serious hepatic dysfunction (CTP 10-15);\n* Chronic kidney disease with glomerular filtration rate (GFR) \\< 29 ml/min/1.73m2\n* Mean blood pressure less than 65 mm Hg or the need of a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg\n* Possible requirement for surgery or bedside tracheostomy in 24 hours\n* Possible requirement for renal replacement therapy in 24 hours\n* Acute severe neurological disorder and any other condition interfering with sedation assessment\n* Abuse of controlled substances or alcohol\n* Pregnancy or lactation\n* Inclusion in another interventional trial in the past 30 days\n* Other conditions deemed unsuitable to be included'}, 'identificationModule': {'nctId': 'NCT05782894', 'briefTitle': 'Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients', 'orgStudyIdInfo': {'id': 'WHUICU202208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam besylate', 'description': 'Remimazolam besylate', 'interventionNames': ['Drug: Remimazolam besylate', 'Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Propofol', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil']}], 'interventions': [{'name': 'Remimazolam besylate', 'type': 'DRUG', 'description': '0\\~2.0mg/kg/h', 'armGroupLabels': ['Remimazolam besylate']}, {'name': 'Propofol', 'type': 'DRUG', 'description': '0.3\\~4.0mg/kg/h', 'armGroupLabels': ['Propofol']}, {'name': 'Remifentanil', 'type': 'DRUG', 'description': '1.5\\~12μg/kg/h', 'armGroupLabels': ['Propofol', 'Remimazolam besylate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yichang Humanwell Pharmaceutical Co., Ltd., China', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}