Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-31 @ 8:23 PM
Study NCT ID:
NCT05241912
Status:
UNKNOWN
Last Update Posted:
2022-02-16
First Post:
2022-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supernormal Oxygen Delivery for Patients With Severe Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004280', 'term': 'Dobutamine'}], 'ancestors': [{'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-06', 'studyFirstSubmitDate': '2022-02-06', 'studyFirstSubmitQcDate': '2022-02-06', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication', 'timeFrame': 'One week after operation', 'description': 'perioperative complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burn Surgery', 'Dobutamine']}, 'descriptionModule': {'briefSummary': 'This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the goal-directed fluid therapy group to further evaluate significant differences in rate of complications during burn surgery.', 'detailedDescription': 'This is a randomized double-blinded study to investigate the effect of control group and the goal-directed fluid therapy group on complications during surgery of the burn patients. The groups are designated as the control group and the oal-directed fluid therapy group to further evaluate significant differences in complications during the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe burn patients\n\nExclusion Criteria:\n\n* Patients or families refuse to sign consent'}, 'identificationModule': {'nctId': 'NCT05241912', 'briefTitle': 'Supernormal Oxygen Delivery for Patients With Severe Burns', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Red Cross Hospital'}, 'officialTitle': 'Supernormal Oxygen Delivery for Patients With Severe Burns：A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022-005-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution.'}, {'type': 'EXPERIMENTAL', 'label': 'Goal-directed fluid group', 'description': 'Intervention: administration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia.\n\nIntraoperative fluid management: administration of 2-4 ml/kg/hr of crystalloid solution.', 'interventionNames': ['Drug: Dobutamine']}], 'interventions': [{'name': 'Dobutamine', 'type': 'DRUG', 'description': 'administration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia to maintain oxygen delivery', 'armGroupLabels': ['Goal-directed fluid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510220', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Liang Bing', 'role': 'CONTACT', 'email': '27291375@qq.com', 'phone': '020-34403854'}], 'facility': 'Guangzhou Red cross hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Red Cross Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate senior doctor', 'investigatorFullName': 'Liang Bing', 'investigatorAffiliation': 'Guangzhou Red Cross Hospital'}}}}