Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-02 @ 8:50 PM
Study NCT ID:
NCT06500156
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Cluster Analysis in Septic Shock Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-07-08', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VO2-response', 'timeFrame': '30 minutes', 'description': 'Percentage increase in VO2 as results of the fluid challenge'}], 'secondaryOutcomes': [{'measure': 'Organ failure', 'timeFrame': '4 days', 'description': 'Assessment of the SOFA score at day 1, 2 and 4'}, {'measure': 'Mortality', 'timeFrame': '28 days', 'description': 'Mortality within the first 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['septic shock', 'hemodynamic resuscitation', 'cardiovascular monitoring'], 'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'Observational study including septic shock patients within 24 hours of ICU admission, monitored with a cardiac output estimation system, with ongoing resuscitation. Hemodynamic and metabolic parameters before and after a fluid challenge (FC) will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion (elevated lactate and/or ScvO2 \\< 70%).\n\nExclusion Criteria:\n\n* Age under 18 years old\n* Uncontrolled hemodynamic instability, defined as the need for significant changes in vasopressor support (\\> 10% from baseline dose) within the 15-minute period prior to, and/or during the administration of fluids.\n* Patients receiving continuous renal replacement therapies, since the CO values obtained from the thermodilution techniques might be potentially affected.'}, 'identificationModule': {'nctId': 'NCT06500156', 'acronym': 'ACMEcat', 'briefTitle': 'Metabolic Cluster Analysis in Septic Shock Patients', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Metabolic Cluster Analysis in Septic Shock Patients Undergoing Hemodynamic Resuscitation. A Multicenter Observational Study', 'orgStudyIdInfo': {'id': '20235121'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Septic shock', 'description': 'Septic shock patients within the first 24 hours of ICU admission, and selected by the attending physician for performing a fluid challenge (FC) due to suspected tissue hypoperfusion.', 'interventionNames': ['Other: Fluid challenge']}], 'interventions': [{'name': 'Fluid challenge', 'type': 'OTHER', 'description': 'Rapid infusion (\\< 15 minutes) of a fluid bolus of crystalloids (200 to 500cc)', 'armGroupLabels': ['Septic shock']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jaume Mesquida, MD', 'role': 'CONTACT', 'email': 'jaume.mesquida@gmail.com', 'phone': '+34937231010'}, {'name': 'Ferran Oller, MD', 'role': 'CONTACT', 'email': 'ferranollersanchez@gmail.com'}, {'name': 'Ferran Oller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jaume Mesquida, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sara Nogales, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Edgar Cortés, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guillem Gruartmoner, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitari Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'Jaume Mesquida, MD', 'role': 'CONTACT', 'email': 'jaume.mesquida@gmail.com', 'phone': '+34937231010'}, {'name': 'Ferran Oller, MD', 'role': 'CONTACT', 'email': 'ferranollersanchez@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jaume Mesquida', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}