Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-01-01 @ 2:23 PM
Study NCT ID:
NCT05718804
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2023-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Microbiota and Sepsis-associated Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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': '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': 'D000069196', 'term': 'Gastrointestinal Microbiome'}], 'ancestors': [{'id': 'D064307', 'term': 'Microbiota'}, {'id': 'D008827', 'term': 'Microbiological Phenomena'}, {'id': 'D058448', 'term': 'Biota'}, {'id': 'D044822', 'term': 'Biodiversity'}, {'id': 'D017753', 'term': 'Ecosystem'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in gut microbiota composition between the two groups', 'timeFrame': 'Within 24 hours of patient enrollment', 'description': 'The differences in the composition of intestinal flora between the two groups were analyzed to identify the correlation with AKI'}], 'secondaryOutcomes': [{'measure': 'IL-6', 'timeFrame': 'Within 24 hours of patient enrollment', 'description': 'the concentration of Interleukin 6 (IL-6)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis-associated kidney injury', 'gut microbiota', 'metagenome', 'prognosis'], 'conditions': ['Sepsis', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': "Sepsis has emerged as one of the important life-threatening infectious diseases with high morbidity and mortality. Sepsis-associated kidney injury (SAKI) is one of the most common and serious complications of sepsis. It has been found that intestinal flora may affect the occurrence and development of a variety of diseases, and may also affect the pathogenesis of multiple SAKI, which is also regulated by host genetic factors. Therefore, the investigators speculate that gut microbiota composition may be associated with susceptibility to SAKI, and there are no studies reporting the association between gut microbiota and SAKI. The investigators intend to carry out a multicenter study in conjunction with the Department of Intensive Care of Qinghai Provincial People's Hospital. The structure and function of intestinal flora in septic patients with renal injury and septic patients less susceptible to renal injury are studied by 16S rDNA amplicon sequencing technology. The differences in composition, diversity and structural stability of intestinal flora between the two groups are analyzed to explore the genera that play a key role in the occurrence of the disease. By analyzing the differences between renal injury and inflammation levels in each group, the correlation between intestinal flora and SAKI, the possible influencing links involved, and the related factors affecting the prognosis of SAKI were revealed. The results of this study are helpful to further elucidate the pathogenesis of SAKI and provide new ideas and methods for the prevention and treatment of SAKI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Sepsis patients who met the inclusion criteria were admitted to the First Affiliated Hospital of Xi'an Jiaotong University and Qinghai Provincial People 's Hospital during the study period.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥18 years；Meet the sepsis definition and diagnostic criteria of Sepsis-3.0 guidelines；No previous history of hypertension or diabetes; No underlying kidney disease such as nephrotic syndrome, no history of rheumatic immune system disease; Normal renal function before onset.\n\nExclusion Criteria:\n\n* Patients with hypertension, diabetes, coronary heart disease, tumor, rheumatism immune system disease and other related diseases that may cause kidney injury; Patients with abnormal renal function before onset; Patients with nephrotic syndrome and other underlying kidney disease; Long-term oral administration of drugs with kidney injury; Previous history of gastrointestinal surgery; No diarrhea related diseases or other gastrointestinal diseases in the past 1 month; The use of antibiotics and probiotics in the past 1 month; Exclusion of other primary or secondary renal damage factors.'}, 'identificationModule': {'nctId': 'NCT05718804', 'acronym': 'GMASAKI', 'briefTitle': 'Gut Microbiota and Sepsis-associated Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'The Relationship Between Gut Microbiota and Sepsis-associated Acute Kidney Injury in Sepsis Patients：Multicenter Observational Study', 'orgStudyIdInfo': {'id': 'XJTU1AF-CRF-2022-016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis-associated kidney injury', 'description': 'Sepsis patients and acute kidney injury No intervention', 'interventionNames': ['Other: Whether renal injury occurred and differences in intestinal flora']}, {'label': 'Sepsis but no renal impairment', 'description': 'Sepsis patients without acute kidney injury', 'interventionNames': ['Other: Whether renal injury occurred and differences in intestinal flora']}], 'interventions': [{'name': 'Whether renal injury occurred and differences in intestinal flora', 'type': 'OTHER', 'otherNames': ['No intervention'], 'description': 'Whether renal injury occurred and differences in intestinal flora', 'armGroupLabels': ['Sepsis but no renal impairment', 'Sepsis-associated kidney injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'contacts': [{'name': 'litao guo', 'role': 'CONTACT', 'email': 'glt02@163.com', 'phone': '0086-029 85323186'}], 'facility': "First affliated hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'collaborators': [{'name': "Qinghai Provincial People 's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}