Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT05155358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2021-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Heat Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018883', 'term': 'Heat Stroke'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, PBMC, plasma exosome miRNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prognosis', 'timeFrame': 'Day 30 and Day 90', 'description': 'Rate of Surviving or Died Participants with Heat Stroke'}], 'secondaryOutcomes': [{'measure': 'Heat Stroke-associated kindey injury', 'timeFrame': 'Day 0, Day 7 and On the day of discharge after improvement', 'description': 'Concentration of Creatinine(Cr)\\>2 mg/dl or Urine output \\< 500ml/Day'}, {'measure': 'Heat Stroke-associated liver injury', 'timeFrame': 'Day 0, Day 7 and On the day of discharge after improvement', 'description': 'Concentration of ALT or AST \\>80 U/L, Concentration of TBIL\\>2mg/dl（34μmol/l）'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heat Stroke', 'Early Waking', 'MODS', 'Proteinosis', 'Liver Injury', 'Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Heat stroke is a clinical syndrome with high incidence and high fatality rate in summer. Patients with liver, kidney, and brain damage are prone to secondary MODS, and the prognosis is poor due to high medical costs. At present, there is no unified diagnostic criteria for acute liver injury associated with heat stroke, and the commonly used prognosis scores are rarely included in liver injury indicators, which is not good for practicality.', 'detailedDescription': 'The project intends to collect the peripheral blood of the normal population, the 24 hours after the onset of heat stroke and the patients in the recovery period, to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to search for indicators related to disease deterioration and prognosis, construct and verify the early warning and prognosis evaluation system of the disease.\n\nOn this basis, the researcher explore cellular and molecular mediated pathological mechanisms of heat stroke, and then clarify the treatment target of heat stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Healthy Volunteers with routine physical examination;\n2. Heat stroke is defined as heat stroke (Heat Stroke, HS) is a serious fatal disease caused by heat injury factors acting on the body, accompanied by multiple organ(liver,kindey, lung ect) dysfunction.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient voluntarily signs an informed consent form;\n2. Adult patients who meet the criteria for heat stroke;\n3. Heat stroke is defined as heat stroke (Heat Stroke, HS) is a serious fatal disease caused by heat injury factors acting on the body, accompanied by multiple organ damage.\n\nExclusion Criteria:\n\n1. Age \\<18 years old or \\>90 years old;\n2. Patients with advanced tumors, Pregnancy or lactation;\n3. Patients who missed out during treatment and whose data are incomplete.'}, 'identificationModule': {'nctId': 'NCT05155358', 'briefTitle': 'Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Heat Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Heat Stroke', 'orgStudyIdInfo': {'id': 'KY20212173'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Healthy volunteers', 'interventionNames': ['Diagnostic Test: Peripheral blood test']}, {'label': 'Patients within the acute phase of disease', 'description': 'Patients within 24 hours after onset', 'interventionNames': ['Diagnostic Test: Peripheral blood test']}, {'label': 'Recovery stage of disease', 'description': 'Organ dysfunction was corrected, The patient had no obvious discomfort.', 'interventionNames': ['Diagnostic Test: Peripheral blood test']}], 'interventions': [{'name': 'Peripheral blood test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Collect peripheral blood to separate and extract plasma, PBMC, and plasma exosomal miRNA, and sequence to find indicators related to disease deterioration and prognosis', 'armGroupLabels': ['Control group', 'Patients within the acute phase of disease', 'Recovery stage of disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '029', 'city': "Xi'an", 'state': 'Shannxi', 'country': 'China', 'contacts': [{'name': 'Yanyan Jia', 'role': 'CONTACT', 'email': 'jiayanyan-2004@hotmail.com', 'phone': '84771794', 'phoneExt': '029'}], 'facility': 'The First Affillated Hospital,the Air Force Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Wen Yin', 'role': 'CONTACT', 'email': 'xjyyyw@126.com', 'phone': '13809186660', 'phoneExt': '86'}, {'name': 'Shanshou Liu', 'role': 'CONTACT', 'email': 'shanshouliu@126.com', 'phone': '15091332280', 'phoneExt': '86'}], 'overallOfficials': [{'name': 'Yanyan Jia', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affillated Hospital,the Air Force Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}