Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-30 @ 11:04 PM
Study NCT ID:
NCT06537557
Status:
RECRUITING
Last Update Posted:
2024-09-20
First Post:
2024-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018883', 'term': 'Heat Stroke'}], 'ancestors': [{'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 188}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cooling rate at 0.5 hours', 'timeFrame': '0.5 hours', 'description': 'The cooling rate at 0.5 hours was calculated in reference to initial body temperature and body temperature at 0.5 hours'}, {'measure': 'Body temperature at 0.5 hours', 'timeFrame': '0.5 hours', 'description': 'Body temperature at 0.5 hour refers to a reading obtained 25 to 35 minutes after admission.'}], 'secondaryOutcomes': [{'measure': 'Body temperature at 2 hours', 'timeFrame': '2 hours', 'description': 'Body temperature at 2 hours refers to a reading taken 100 to 140 minutes after admission'}, {'measure': 'in-hospital mortality', 'timeFrame': '30 days', 'description': 'Mortality from any cause during hospitalization'}, {'measure': '3-month mortality rate', 'timeFrame': '3 months', 'description': 'death within 3 months after emergency visit'}, {'measure': 'Number of participants with other complications', 'timeFrame': '3 months', 'description': 'including heart failure, renal failure, coagulation disorders, respiratory failure, neurological sequelae, etc.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heat Stroke']}, 'descriptionModule': {'briefSummary': 'Heat stroke is a life-threatening clinical syndrome characterized by an imbalance between heat production and heat dissipation in the body, resulting from exposure to hot and humid environments and/or strenuous exercise. It is defined by an elevated core temperature exceeding 40°C and central nervous system abnormalities, accompanied by multi-organ dysfunction. The severity of cellular and tissue damage in heat stroke patients depends on the peak temperature reached and the duration of hyperthermia. Rapid reduction of core temperature can halt cellular damage, quickly reverse organ dysfunction, and improve patient outcomes. Therefore, early identification and rapid cooling are crucial to prevent irreversible damage and death in heat stroke patients. However, there is a lack of systematic and specific protocols to guide emergency medical staff in the standardized and effective management of body temperature in heat stroke patients. To address this, our research team previously developed an early in-hospital temperature management protocol for heat stroke patients based on the best available evidence, expert consultations, and expert panel meetings. This study aims to validate the feasibility and effectiveness of the protocol through clinical research, providing a basis for clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the emergency department and diagnosed with heat stroke according to the China expert consensus on Heat Stroke\n\nExclusion Criteria:\n\n* transferred from another hospital and body temperature \\< 39.5℃; discharged within 4 hours, and subsequent body temperature or outcomes were unavailable; required immediate cardiopulmonary resuscitation; had other serious diseases, such as massive cerebral haemorrhage or severe trauma.'}, 'identificationModule': {'nctId': 'NCT06537557', 'briefTitle': 'Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Application of an Early In-Hospital Temperature Management Protocol for Heat Stroke Patients', 'orgStudyIdInfo': {'id': '2024-0511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'Using the early in-hospital temperature management protocol for heat stroke patients developed in our previous research, we will implement early identification, rapid cooling, and precise target temperature management for this group of patients.', 'interventionNames': ['Other: the early in-hospital temperature management protocol for heat stroke patients']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'We will retrospectively collect data on heat stroke patients who were visited before the implementation of the early in-hospital temperature management protocol between 2021 and 2022, meaning this group of patients received temperature management according to the original methods used by their respective hospitals.'}], 'interventions': [{'name': 'the early in-hospital temperature management protocol for heat stroke patients', 'type': 'OTHER', 'description': 'The early in-hospital temperature management protocol for heat stroke includes early identification, selection of cooling methods for rapid cooling, precise target temperature management, and dynamic monitoring. Effective temperature management will be implemented for heat stroke patients to improve their outcomes.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '321300', 'city': 'Guli', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huimin Ma', 'role': 'CONTACT', 'email': 'ykmhm@qq.com', 'phone': '86-0579-7111834'}], 'facility': 'Yongkang First People's Hospital', 'geoPoint': {'lat': 28.88162, 'lon': 120.03308}}, {'city': 'Dongyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuying Xu', 'role': 'CONTACT'}], 'facility': "Dongyang People's Hospital", 'geoPoint': {'lat': 29.26778, 'lon': 120.22528}}, {'city': 'Hanzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuqin Feng, PRO', 'role': 'CONTACT', 'email': 'fengxiuqin@zju.edu.cn', 'phone': '+86 13757119151'}, {'name': 'Lan Chen, M.Med.', 'role': 'CONTACT', 'phone': '+86 13819987120'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 26.4965, 'lon': 99.437}}, {'city': 'Jinhua', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sunying Wu', 'role': 'CONTACT'}], 'facility': 'Jinhua Municipal Central Hospital', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'city': 'Jinhua', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liyun Lu', 'role': 'CONTACT', 'email': '779676709@qq.com'}], 'facility': "Jinhua People's Hospital", 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'city': 'Lanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoling Yang', 'role': 'CONTACT'}], 'facility': "Lanxi People's Hospital", 'geoPoint': {'lat': 29.21588, 'lon': 119.47156}}, {'city': 'Yiwu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhumei Gong', 'role': 'CONTACT', 'email': '179219712@qq.com'}], 'facility': 'Yiwu Central Hospital', 'geoPoint': {'lat': 29.31506, 'lon': 120.07676}}], 'centralContacts': [{'name': 'Xiuqin Feng', 'role': 'CONTACT', 'email': 'fengxiuqin@zju.edu.cn', 'phone': '13757119151'}, {'name': 'lan chen', 'role': 'CONTACT', 'email': 'jhchenlan2003@hotmail.com', 'phone': '13819987120'}], 'overallOfficials': [{'name': 'lan chen', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinhua Municipal Central Hospital', 'class': 'OTHER'}, {'name': "Dongyang People's Hospital", 'class': 'OTHER'}, {'name': "Lanxi People's Hospital", 'class': 'OTHER'}, {'name': 'Yiwu Central Hospital', 'class': 'OTHER'}, {'name': 'Jinhua People's Hospital', 'class': 'UNKNOWN'}, {'name': 'Hangzhou Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}