Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT00372502
Status:
COMPLETED
Last Update Posted:
2009-01-14
First Post:
2006-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D004630', 'term': 'Emergencies'}], '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': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-12', 'studyFirstSubmitDate': '2006-09-06', 'studyFirstSubmitQcDate': '2006-09-06', 'lastUpdatePostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'In-hospital'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sepsis', 'shock', 'emergency department', 'resuscitation'], 'conditions': ['Severe Sepsis', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '23740148', 'type': 'DERIVED', 'citation': 'Puskarich MA, Trzeciak S, Shapiro NI, Albers AB, Heffner AC, Kline JA, Jones AE. Whole blood lactate kinetics in patients undergoing quantitative resuscitation for severe sepsis and septic shock. Chest. 2013 Jun;143(6):1548-1553. doi: 10.1378/chest.12-0878.'}, {'pmid': '20179283', 'type': 'DERIVED', 'citation': 'Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there is equivalence between two different methods of treating patients with severe bloodstream infection called sepsis. We will randomly assign patients to one of two treatment methods. One of the treatment methods is the current standard of care and uses an infrared sensor on the end of a catheter to determine the adequacy of treatment. The second treatment method is identical to the first but instead of the infrared sensor a blood test that is performed as a part of standard care (with blood drawn from the catheter) will be used to determine the adequacy of treatment. This study will attempt to determine an easier method of guiding treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Suspected infection\n2. Any two of four criteria of systemic inflammatory response\n3. SBP \\< 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate \\> 4 mmol/L (severe sepsis).\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. Pregnancy\n3. Established "Do Not Resuscitate" orders prior to enrollment\n4. Primary diagnosis other than sepsis\n5. Requirement for immediate surgery in \\< 6 hours from admission\n6. Any absolute contraindication to central venous catheterization'}, 'identificationModule': {'nctId': 'NCT00372502', 'acronym': 'LactATES', 'briefTitle': 'Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation', 'organization': {'class': 'NIH', 'fullName': 'National Institute of General Medical Sciences (NIGMS)'}, 'officialTitle': 'Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial', 'orgStudyIdInfo': {'id': '1K23GM076652', 'link': 'https://reporter.nih.gov/quickSearch/1K23GM076652', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Procedure: Standard EGDT']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Procedure: Modified EGDT']}], 'interventions': [{'name': 'Modified EGDT', 'type': 'PROCEDURE', 'description': 'Early goal directed therapy with lactate clearance', 'armGroupLabels': ['2']}, {'name': 'Standard EGDT', 'type': 'PROCEDURE', 'description': 'Early goal directed therapy', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Alan E Jones, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Carolinas Medical Center'}, {'name': 'Jeffrey A Kline, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Carolinas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Alan E Jones, MD; Assistant Research Director', 'oldOrganization': 'Carolinas Medical Center'}}}}