Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 12:50 AM
Study NCT ID:
NCT05229328
Status:
UNKNOWN
Last Update Posted:
2023-01-31
First Post:
2021-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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': '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'}]}}, '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': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-28', 'studyFirstSubmitDate': '2021-11-14', 'studyFirstSubmitQcDate': '2022-02-07', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Surviving or Died Participants with sepsis', 'timeFrame': 'Day 30', 'description': 'Prognosis'}, {'measure': 'Rate of Surviving or Died Participants with sepsis', 'timeFrame': 'Day 90', 'description': 'Prognosis'}], 'secondaryOutcomes': [{'measure': 'Sepsis-associated liver injury', 'timeFrame': 'Day 0', 'description': 'Concentration of Alanine aminotransferase(ALT) \\>80 U/L or Glutamine oxaloacetic transaminase (GOT,AST) \\>80 U/L, Concentration of total bilirubin(TBIL)\\>2mg/dl（34μmol/l）'}, {'measure': 'Sepsis-associated kidney injury', 'timeFrame': 'Day 0', 'description': 'Concentration of Creatinine(Cr)\\>2 mg/dl or Urine output \\< 500ml/Day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Prognosis', 'Liver Injury', 'Kidney Injury', 'Early Waking']}, 'descriptionModule': {'briefSummary': 'Sepsis is a clinical syndrome with high morbidity and high fatality rate in emergency department. Patients with acute liver or kidney injury are more likely to develop Multiple Organ Dysfunction Syndrome(MODS) secondary to the non-hepatic injury group, and the prognosis deteriorates significantly. At present, there is no unified diagnostic criteria for acute liver injury associated with sepsis, and the commonly used prognostic evaluation system is 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, 24 hours after the onset of sepsis and patients in the recovery period. We will separate and extract plasma, Peripheral Blood Mononuclear Cell(PBMC), and plasma exosomal miRNA, and sequence to find indicators related to disease deterioration and prognosis. And then, we will construct and verify the early warning and prognosis evaluation system.\n\nOn this basis, the researcher explore cellular and molecular mediated pathological mechanisms of sepsis, and then clarify the treatment target of sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Healthy Volunteers;\n2. Adult patients who meet the criteria for sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.\n3. Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient who voluntarily signs an informed consent form;\n2. Adult patients who meet the criteria for sepsis, who is registration to the hospital within 24 hours of onset;\n3. SEPSIS is defined as the sequential organ failure assessment (SOFA) score ≥ 2 within 24 hours after admission, accompanied by at least one site of infection;\n4. Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure(MAP) 65 mm Hg and having a serum lactate level \\>2 mmol/L (18 mg/dL) despite adequate volume resuscitation.\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': 'NCT05229328', 'briefTitle': 'Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Study on the Establishment of a System for Early Warning and Prognostic Evaluation', 'orgStudyIdInfo': {'id': 'KY20212172'}}, '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 phase of disease', 'description': 'Inflammation was controlled, shock was corrected, and the patient remained fever free for 3 consecutive days.', '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 phase of disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shannxi', 'status': 'RECRUITING', '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'}}}}