Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-01-20 @ 10:40 AM
Study NCT ID:
NCT03256461
Status:
UNKNOWN
Last Update Posted:
2017-08-22
First Post:
2017-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactate Clearance Goal-directed Therapy in Sepsis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D043322', 'term': 'Lactase'}, {'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D001616', 'term': 'beta-Galactosidase'}, {'id': 'D005696', 'term': 'Galactosidases'}, {'id': 'D006026', 'term': 'Glycoside Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-07', 'size': 459105, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-08-07T11:46', 'hasProtocol': True}, {'date': '2017-08-07', 'size': 192955, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-08-07T11:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This trial is a prospective, multicenter, single-blind, parallel-group, central-randomized, controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-21', 'studyFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2017-08-21', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-d mortality', 'timeFrame': 'Four years', 'description': 'All-cause mortality at 28 days'}], 'secondaryOutcomes': [{'measure': 'ICU Length of stay', 'timeFrame': 'Four years', 'description': 'Length of stay in the intensive care unit (ICU)'}, {'measure': 'Hospital Length of stay', 'timeFrame': 'Four years', 'description': 'Length of stay in hospital'}, {'measure': '90-d mortality', 'timeFrame': 'Four years', 'description': 'All-cause mortality at 90 days'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Four years', 'description': 'All-cause mortality during hospitalization'}, {'measure': 'In-ICU mortality', 'timeFrame': 'Four years', 'description': 'All-cause mortality during ICU stay'}, {'measure': 'Administered treatments', 'timeFrame': 'Four years', 'description': 'Administered treatments included: crystalloid volume, vasopressor administered, dobutamine, red blood cell(RBC) transfusion, mechanical ventilation, renal-replacement therapy'}, {'measure': 'SOFA at 24h', 'timeFrame': 'Four years', 'description': 'Sequential Organ Failure Assessment(SOFA) at 24 hours'}, {'measure': 'Adverse events', 'timeFrame': 'Four years', 'description': 'Proportion of patients reporting treatment-emergent adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'lactate clearance', 'protocolized resuscitation'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'Serum lactate level is depended on the balance between lactate production and clearance. It is seen as a sensitive indicator reflecting not only the low systemic perfusion but microcirculatory dysfunction which cause global or regional tissue hypoxia (as a result of impaired mitochondrial oxidation). 2016 Surviving Sepsis Campaign guideline stated "We suggest guiding resuscitation to normalize lactate in patients with elevated lactate levels as a marker of tissue hypoperfusion", with weak recommendation and low quality of evidence. Several trials which evaluated the resuscitation strategy included lactate clearance as a target while based on 2.0 diagnostic criteria for sepsis, finally showed conflicting results. The aim of this study is to explore the feasibility of lactate clearance guide resuscitation in sepsis that defined by The Third International Consensus Definitions for Sepsis and Septic shock through multi-center, central-randomization clinical trial.', 'detailedDescription': "Sepsis remains a great challenge for clinicians, early goal-directed therapy(EGDT), referring to a number of target-achieving indicators including systemic central venous oxygen saturation(ScvO2) after initial fluid resuscitation within 6 hours, has been one of the main treatment for sepsis. ScvO2 is the only indicator that reflects tissue oxygen metabolism. However, there're studies confirmed that ScvO2 oriented EGDT cannot reduce the mortality of sepsis. So it is important to find out a more effective indicator. Lactic acid is a product of anaerobic metabolism of the body, lactate clearance has been found to effectively predict the prognosis of sepsis. Few studies have shown that lactate clearance oriented fluid resuscitation can be of benefit in patients with sepsis. Nevertheless, whether lactate clearance could be combined with sepsis Bundle as a new marker to improve the prognosis remains a problem. The objective of this study is to discuss the feasibility of lactate clearance oriented sepsis treatment through multi-center clinical trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 17 years old.\n* Primary diagnosis is sepsis, means being confirmed or suspected infection while have at least 2 points of quickSOFA(qSOFA).\n* Be transferred to intensive care unit (ICU) for the first time during this hospitalization.\n* Elevated lactate ≥3.0mmol/L.\n\nExclusion Criteria:\n\n* Acute hemorrhage uncontrolled.\n* Pregnancy.\n* Known liver disease - Child-Pugh classes C, acute hepatic failure, severe hepatopathy accompany with prominent portal hypertension.\n* Known being in an immunosuppressive state:\n\n 1. Suffering from any disease that is unrelated with sepsis that severely inhibits the immune to infection, such as: active hematological or lymphoma malignancy, or during immunosuppressive therapy, such as chemotherapy or radiotherapy.\n 2. Known human immunodeficiency virus (HIV) serology positive.\n* Known chronic kidney disease.\n* Suffering from any disease that affects lactate kinetics, such as mitochondrial encephalopathy, congenital hyperlipidemia, Wernicke encephalopathy, etc. Or other probable cause of hyperlactatemia.\n* Took any drugs that affect lactate kinetics within the effective time window, such as taking metformin or phenylephrine within 1 week.\n* Suffering from any disease that restricts resuscitation, such as heart failure, cardiac surgery, severe heart disease etc, or suffered from a cardio-pulmonary resuscitation,.'}, 'identificationModule': {'nctId': 'NCT03256461', 'briefTitle': 'Lactate Clearance Goal-directed Therapy in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Multi-center Clinical Trial of Lactate Clearance Goal-directed Fluid Resuscitation in Patients With Sepsis', 'orgStudyIdInfo': {'id': 'LCGRIS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactate clearance 10% target group', 'description': 'Lactate clearance falls by 10-percent every two hours.', 'interventionNames': ['Behavioral: Lactate clearance 10% target group']}, {'type': 'EXPERIMENTAL', 'label': 'Lactate clearance 20% target group', 'description': 'Lactate clearance falls by 20-percent every two hours.', 'interventionNames': ['Behavioral: Lactate clearance 20% target group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard EGDT group', 'description': 'Refer to the Surviving Sepsis Campaign(SSC) 2012 sepsis guidelines within 6 h liquid resuscitation.', 'interventionNames': ['Behavioral: Standard EGDT group']}], 'interventions': [{'name': 'Lactate clearance 10% target group', 'type': 'BEHAVIORAL', 'otherNames': ['Lac% 10% group'], 'description': 'Participants receive the protocolized resuscitation to achieve the goal of 10-percent lactate clearance every two hours within the initial six hours of treatment.', 'armGroupLabels': ['Lactate clearance 10% target group']}, {'name': 'Lactate clearance 20% target group', 'type': 'BEHAVIORAL', 'otherNames': ['Lac% 20% group'], 'description': 'Participants receive the protocolized resuscitation to achieve the goal of 20-percent lactate clearance every two hours within the initial six hours of treatment.', 'armGroupLabels': ['Lactate clearance 20% target group']}, {'name': 'Standard EGDT group', 'type': 'BEHAVIORAL', 'otherNames': ['EGDT group'], 'description': 'Participants receive the strategy of early goal-directed treatment of sepsis fluid resuscitation.', 'armGroupLabels': ['Standard EGDT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongqing Chen, Ph.D', 'role': 'CONTACT', 'email': '13503049103@163.com', 'phone': '+86 20 6164 1886'}, {'name': 'Yaoyuan Zhang, Master', 'role': 'CONTACT', 'email': 'm18620660446@163.com'}, {'name': 'Weijun Fu, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xingui Dai, Master', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yaoyuan Zhang, Master', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'NanFang hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Chen Zhongqing, Ph.D', 'role': 'CONTACT', 'email': '13503049103@163.com', 'phone': '020-61641886'}], 'overallOfficials': [{'name': 'Chen Zhongqing, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}