Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT06376318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shock and Acute Conditions OutcOmes Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D012773', 'term': 'Shock, Surgical'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014662', 'term': 'Vasoconstrictor Agents'}], 'ancestors': [{'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '1 year'}, {'measure': 'Renal replacement therapy use rate', 'timeFrame': '28 days'}, {'measure': 'Mechanical circulatory support use rate', 'timeFrame': '28 days'}, {'measure': 'Vasopressors and inotropes-free days', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shock', 'heterogeneity of treatment effect', 'biomarkers', 'machine learning'], 'conditions': ['Circulatory Shock', 'Sepsis', 'Cardiogenic Shock', 'Major Trauma', 'Surgical Shock']}, 'referencesModule': {'references': [{'pmid': '37592121', 'type': 'BACKGROUND', 'citation': 'Soussi S, Dos Santos C, Jentzer JC, Mebazaa A, Gayat E, Poss J, Schaubroeck H, Billia F, Marshall JC, Lawler PR. Distinct host-response signatures in circulatory shock: a narrative review. Intensive Care Med Exp. 2023 Aug 18;11(1):50. doi: 10.1186/s40635-023-00531-5.'}, {'pmid': '37338937', 'type': 'BACKGROUND', 'citation': 'Sarma D, Jentzer JC, Soussi S. Cardiogenic shock: a major challenge for the clinical trialist. Curr Opin Crit Care. 2023 Aug 1;29(4):371-380. doi: 10.1097/MCC.0000000000001066. Epub 2023 Jun 19.'}, {'pmid': '37589609', 'type': 'BACKGROUND', 'citation': 'Mebazaa A, Soussi S. Precision Medicine in Cardiogenic Shock: We Are Almost There! JACC Heart Fail. 2023 Oct;11(10):1316-1319. doi: 10.1016/j.jchf.2023.06.024. Epub 2023 Aug 16. No abstract available.'}, {'pmid': '33216849', 'type': 'BACKGROUND', 'citation': "Soussi S, Collins GS, Juni P, Mebazaa A, Gayat E, Le Manach Y. Evaluation of Biomarkers in Critical Care and Perioperative Medicine: A Clinician's Overview of Traditional Statistical Methods and Machine Learning Algorithms. Anesthesiology. 2021 Jan 1;134(1):15-25. doi: 10.1097/ALN.0000000000003600."}, {'pmid': '39802301', 'type': 'DERIVED', 'citation': "Soussi S, Tarvasmaki T, Kimmoun A, Ahmadiankalati M, Azibani F, Dos Santos CC, Duarte K, Gayat E, Jentzer JC, Harjola VP, Hibbert B, Jung C, Johan L, Levy B, Lu Z, Lawler PR, Marshall JC, Poss J, Sadoune M, Nguyen A, Raynor A, Peoc'h K, Thiele H, Mathew R, Mebazaa A. Identifying biomarker-driven subphenotypes of cardiogenic shock: analysis of prospective cohorts and randomized controlled trials. EClinicalMedicine. 2024 Dec 18;79:103013. doi: 10.1016/j.eclinm.2024.103013. eCollection 2025 Jan."}]}, 'descriptionModule': {'briefSummary': 'In-hospital mortality of patients admitted in the intensive care unit (ICU) for circulatory shock remains high (between 20 and 40%).\n\nCurrently, there are no markers that allow us to classify patients with circulatory shock at higher risk of early and late bad outcomes, or who may better respond to a specific intervention.\n\nTo understand the contribution of biological heterogeneity to circulatory shock independently from its etiology, the ShockCO-OP Research Program aims to use clustering approaches to re-analyze existing clinical and molecular data from several large European and North American prospective cohorts and clinical trials.\n\nThis will enable an improvement in risk prediction and a better patient selection in future clinical trials to assess a personalized therapy (i.e., prospective enrollment based on a biological/molecular signature).', 'detailedDescription': 'Traditionally, circulatory shock subgroups are defined according to hemodynamic profile (e.g., hypovolemic, distributive, cardiogenic) and etiology (e.g., trauma, infection, myocardial infarction among others) and are incorrectly considered as homogeneous clinical syndromes. Emerging translational evidence highlights the existing molecular heterogeneity in the circulatory shock syndrome. Such findings raise a major issue in assessing neutral clinical trial results in circulatory shock as a given intervention effect (e.g., fluid management, vasopressors/inotropes, mechanical circulatory support) may preferentially impact different subgroups (i.e., heterogeneity of treatment effect).\n\nAccordingly, identifying distinct biological subphenotypes with different mechanistic signatures may provide new insights regarding the pathophysiology of circulatory shock. This may allow predictive enrichment (i.e., identifying those patients most likely to benefit from a particular therapy) and biomarker-driven or phenotype-driven patient selection in future clinical trials to assess a personalized therapy (i.e., prospective enrollment based on a biological signature).\n\nThe ShockCO-OP Research Program aims to use unsupervised model-based clustering (i.e., regardless of outcome) to reanalyze existing clinical and biological data in several European and North American prospective cohorts and clinical trials to identify distinct biomarker-driven subphenotypes in circulatory shock syndromes, their underlying molecular signatures (proteomics, transcriptomics), their association with outcome and their response to different interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with circulatory shock on admission independently from its etiology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with circulatory shock on admission (i.e., the reported main cause of admission is septic shock, cardiogenic shock or hypovolemic/hemorrhagic shock).\n2. Patients who required vasopressors infusion and presented signs of tissue hypoperfusion (e.g., altered mental state (Glasgow coma scale≤ 14), oliguria (urine output of \\< 0.5 ml/kg/h for at least six hours) or a serum lactate level of ≥2 mmol/l) within the first 24 h after admission.\n\nExclusion Criteria:\n\n1. Mechanical circulatory support on admission\n2. Serious arrythmia (e.g., rapid atrial fibrillation or ventricular tachycardia/fibrillation) on admission\n3. Deceased patients within the first 24 hours after admission.'}, 'identificationModule': {'nctId': 'NCT06376318', 'acronym': 'ShockCO-OP', 'briefTitle': 'Shock and Acute Conditions OutcOmes Platform', 'organization': {'class': 'OTHER', 'fullName': 'Saint-Louis Hospital, Paris, France'}, 'officialTitle': 'Beyond the Syndromic Approach in Critical Care: Identifying Biomarker-driven Subphenotypes of Circulatory Shock', 'orgStudyIdInfo': {'id': '19-138'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Inotrope', 'type': 'DRUG', 'otherNames': ['Vasopressor'], 'description': 'Vasopressors: Norepinephrine, vasopressin Inotropes: Epinephrine, Dobutamine, Milrinone'}, {'name': 'Mechanical circulatory support', 'type': 'DEVICE', 'description': 'Intra-aortic balloon pump Extracorporeal membrane oxygenation (ECMO)'}, {'name': 'anti-bodies', 'type': 'DRUG', 'description': 'Anti-Dipeptidyl peptidase 3 (DPP3), Anti-Bioactive adrenomedullin (bio-ADM)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Claudia dos Santos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}, {'name': 'Alexandre Mebazaa, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'St Louis and Lariboisiere Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint-Louis Hospital, Paris, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Helsinki', 'class': 'OTHER'}, {'name': 'University of Ottawa', 'class': 'OTHER'}, {'name': 'University of Leipzig', 'class': 'OTHER'}, {'name': 'University of Nancy', 'class': 'OTHER'}, {'name': 'McGill University', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'University of Paris 5 - Rene Descartes', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sabri SOUSSI', 'investigatorAffiliation': 'University of Toronto'}}}}