Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-04 @ 11:12 AM
Study NCT ID:
NCT05921695
Status:
RECRUITING
Last Update Posted:
2024-09-20
First Post:
2023-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Heat Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018883', 'term': 'Heat Stroke'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-06-18', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute kidney injury', 'timeFrame': 'up to 90 days', 'description': 'Acute kidney injury was defined as increase in serum creatinine by 50% within 7 days, or increase in serum creatinine by 0.3 mg/dl (26.5μmol/l) within 2 days, or oliguria'}], 'secondaryOutcomes': [{'measure': 'Continuous renal replacement therapy', 'timeFrame': 'up to 90 days', 'description': 'number of participants need continuous renal replacement therapy'}, {'measure': 'length of ICU stay', 'timeFrame': 'up to 90 days', 'description': 'The length patient stay in ICU'}, {'measure': 'in-hospital mortality', 'timeFrame': 'up to 90 days', 'description': 'number of participants dead in hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heat stroke', 'normal saline', 'acute kidney injury', 'mortality'], 'conditions': ['Heat Stroke']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to compare the effect of high chlorine solution such as normal saline and non-high chlorine solution such as sodium lactate ringer's solution on renal function in patients with heat stroke. The main question it aims to answer is whether limiting the amount of normal saline infusion during emergency department can lower the incidence of acute kidney injury and mortality in patients with heat stroke.\n\nParticipants will receive a free normal saline infusion during the emergency department according to the study design, or a restricted normal saline infusion while using sodium lactate Ringer's instead.\n\nResearchers will compare the normal saline infusion group and sodium lactate Ringer's group to see if limiting the amount of normal saline infusion during emergency department can lower the incidence of acute kidney injury and mortality in patients with heat stroke."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years\n* diagnosed as heat stroke\n* Informed consent from patients or family members.\n\nExclusion Criteria:\n\n* need immediate cardiopulmonary resuscitation\n* transferred from another hospital\n* with original end-stage renal disease or dialysis\n* with severe organ damage\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT05921695', 'briefTitle': 'The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Heat Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Relationship Between Normal Saline Infusion and Acute Kidney Injury in Patients With Heat Stroke', 'orgStudyIdInfo': {'id': '20230506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Saline infusion group', 'description': 'During the emergency department, the normal saline infusion was not restricted.', 'interventionNames': ['Drug: Normal Saline infusion and Ringer lactate infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Ringer lactate infusion group', 'description': 'Use ringer lactate or other balanced crystallographic solution instead of normal saline. Strictly limit the amount of normal saline infusion. Normal saline will only be infused by medical advice if the patient has hypochloremia or needs saline as solvent.', 'interventionNames': ['Drug: Normal Saline infusion and Ringer lactate infusion']}], 'interventions': [{'name': 'Normal Saline infusion and Ringer lactate infusion', 'type': 'DRUG', 'otherNames': ["NS and Lactated Ringer's solution"], 'description': 'The heat stroke patients will be infused with different chlorine concentrations fluid during the emergency department.', 'armGroupLabels': ['Normal Saline infusion group', 'Ringer lactate infusion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '321300', 'city': 'Guli', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huimin Ma', 'role': 'CONTACT', 'email': 'ykmhm@qq.com', 'phone': '8605797111834'}], 'facility': 'YongKang First People's Hospital', 'geoPoint': {'lat': 28.88162, 'lon': 120.03308}}, {'city': 'Yiwu', 'state': 'Zhejiang', '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}}, {'city': 'Dongyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuying Xu', 'role': 'CONTACT'}], 'facility': "Dongyang People's Hospital", 'geoPoint': {'lat': 29.26778, 'lon': 120.22528}}, {'zip': '310000', 'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuqin Feng', 'role': 'CONTACT', 'email': 'fengxiuqin@zju.edu.cn', 'phone': '+8613757119151'}, {'name': 'Lan Chen', 'role': 'CONTACT', 'email': 'jhchenlan2003@hotmail.com', 'phone': '+8613819987120'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'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}}], 'centralContacts': [{'name': 'Xiuqin Feng, PRO', 'role': 'CONTACT', 'email': 'fengxiuqin@zju.edu.cn', 'phone': '8613757119151'}, {'name': 'Lan Chen, PHD', 'role': 'CONTACT', 'email': 'jhchenlan2003@hotmail.com', 'phone': '+8613819987120'}], 'overallOfficials': [{'name': 'Lan Chen, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yiwu Central Hospital', 'class': 'OTHER'}, {'name': "Jinhua People's Hospital", 'class': 'OTHER'}, {'name': 'Jinhua Municipal Central Hospital', 'class': 'OTHER'}, {'name': "Dongyang People's Hospital", 'class': 'OTHER'}, {'name': "Lanxi People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}