Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-09 @ 4:51 PM
Study NCT ID:
NCT04155060
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognostic Value of Lactate is Different Among Septic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D065906', 'term': 'Hyperlactatemia'}], '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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2019-11-05', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome was 28-day mortality', 'timeFrame': 'up to at least 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyperlactatemia'], 'conditions': ['Sepsis', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients. Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting. DM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM.', 'detailedDescription': 'Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients.\n\nCurrently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting.Nevertheless, the value of lactate for predicting sepsis is still controversial.The reasons for the different cutoff value may be due to the fact that sepsis is a heterogeneous disease which has already been defined by a number of clinical, laboratory and radiologic criteria, rather than specific pathologic findings. Therefore, we hypothesized that the discrepancy clinical value of lactate may be resulted from the heterogeneous feature of sepsis.\n\nDM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Septic patients were recruited with lactate level obtained, and admission to the intensive care unit (ICU) .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:18 years or older, informed consent signed, admission serum lactate level obtained, and admission to the hospital with sepsis or septic shock diagnosis.\n\n\\-\n\nExclusion Criteria:congenital metabolic and psychiatric diseases and clinical data deficiency.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04155060', 'briefTitle': 'The Prognostic Value of Lactate is Different Among Septic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Prognostic Value of Lactate is Different Among Septic Patients With or Without Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PROMPT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DM group , non-DM group', 'description': 'Septic patients were divided into the DM group and non-DM group, based on their comorbidity'}, {'label': 'high lactate group,low lactate group', 'description': 'high lactate group (lactate \\> 2 mmol/L) and low lactate group (lactate ≤ 2 mmol/L), according to the admission lactate level.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': '180 Fenglin Road', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}