Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT04537767
Status:
UNKNOWN
Last Update Posted:
2020-09-03
First Post:
2020-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Esmolol on Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C036604', 'term': 'esmolol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2020-06-14', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'REE', 'timeFrame': 'Day 7 after enrollment', 'description': 'Resting energy expenditure'}], 'secondaryOutcomes': [{'measure': '28-day mortality rate', 'timeFrame': 'Day 28 after enrollment', 'description': '28-day mortality rate'}, {'measure': 'HR control rate', 'timeFrame': '24 hours after enrollment', 'description': 'target heart rate control rate'}, {'measure': 'Vasoactive drug administration dose', 'timeFrame': 'Day 1/3/7 after enrollment', 'description': 'Vasoactive drug administration dose'}, {'measure': 'Concentration of Lac', 'timeFrame': 'Day 1/3/7 after enrollment', 'description': 'Concentration of lactic acid'}, {'measure': 'O2ER', 'timeFrame': 'Day 1/3/7 after enrollment', 'description': 'oxygen extraction rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'septic shock', 'esmolol'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.', 'detailedDescription': 'Severe sepsis, septic shock, and their complications have become the major healthcare problem that affects millions of people each year, resulting in high mortality rates. Septic responses have an extremely complex chain of events including inflammatory and anti-inflammatory processes, humoral and cellular reactions, and cardiocirculatory abnormalities. Esmolol may have some potential in treating septic shock and sepsis. The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sepsis patients\n* HR\\>100bpm 6h after admission\n* with CVC and ScvO2\\>65%\n\nExclusion Criteria:\n\n* age \\<18 years,\n* used β-blocker before,\n* cardiac dysrhythmias,\n* need for an inotropic agent,\n* valvular heart disease,\n* hemoglobin\\>6g/L\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT04537767', 'briefTitle': 'The Effect of Esmolol on Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Effect of Esmolol on Patients With Sepsis', 'orgStudyIdInfo': {'id': 'ES-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ES group', 'description': 'Patients randomly assigned to the ES group were treated with esmolol to control the heart rate to the target range.', 'interventionNames': ['Drug: Esmolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Patients randomly assigned to the control group were treated with placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Esmolol', 'type': 'DRUG', 'description': 'The protocol required a titrated esmolol infusion commenced at 25 mg/ h, with an upper dose limit of 2000 mg/h, to maintain the HR between 75 and 90 bpm in ES group. The control group were treated with placebo.', 'armGroupLabels': ['ES group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['control group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}