Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT07278167
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2025-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Risk Factors and Prognostic Predictive Value in Sepsis Patients With Nutritional Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2025-11-30', 'studyFirstSubmitQcDate': '2025-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day clinical outcome', 'timeFrame': '28day'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Nutritional Risk']}, 'descriptionModule': {'briefSummary': 'Sepsis is a common critical illness in intensive care units, characterized by systemic inflammatory response, immune dysfunction, microcirculatory issues, and multi-organ failure. These factors lead to high mortality rates and poor prognoses for patients. Nutritional risk is a significant complication in patients with sepsis, with a prevalence of 38% - 78. Sepsis-induced hypermetabolism and hypercatabolism result in increased energy expenditure and accelerated protein breakdown in affected patients, which subsequently exacerbates the risk of malnutrition. Malnutrition weakens immune function, reduces resistance to infections, and impairs immune regulation in sepsis patients. It worsens organ dysfunction, prolongs ICU hospitalization, and increases morbidity and mortality rates. Early identification and intervention for potential risk factors in patients with sepsis, particularly those with nutritional risk, is crucial for enhancing their prognosis. There is a notable lack of sensitive indicators for assessing the prognosis of sepsis patients at nutritional risk. Recent studies have begun exploring physical assessment measures in ICU settings as accessible and noninvasive tools for evaluation. This study aims to investigate the predictive value of nutritional laboratory indicators and physical measurements regarding the 28-day outcomes of ICU patients with sepsis and nutritional risk, providing a foundation for early clinical intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sepsis with nutritional risk', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Met the diagnostic criteria for sepsis 3.0\n2. Met the diagnostic criteria for nutritional risk (NRS-2002 score ≥ 3)\n3. ICU stay≥2 days\n4. Age ≥ 18\n\nExclusion Criteria:\n\n1. Edema\n2. Tumor patients\n3. Pregnancy\n4. Lack of complete laboratory results'}, 'identificationModule': {'nctId': 'NCT07278167', 'briefTitle': 'Analysis of Risk Factors and Prognostic Predictive Value in Sepsis Patients With Nutritional Risk', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Inner Mongolia Medical University'}, 'officialTitle': 'Analysis of Risk Factors and Predictive Value for 28-Day Mortality in Patients With Sepsis and Nutritional Risk', 'orgStudyIdInfo': {'id': 'AHInnerMongolia-NT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'survivors/non-survivors', 'interventionNames': ['Other: Retrospective data analysis, no intervention']}], 'interventions': [{'name': 'Retrospective data analysis, no intervention', 'type': 'OTHER', 'description': 'Retrospective data analysis, no intervention', 'armGroupLabels': ['survivors/non-survivors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hohhot', 'country': 'China', 'facility': 'Jing Lin', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Inner Mongolia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}