Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-29 @ 3:43 AM
Study NCT ID:
NCT05954260
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Dysfunction in Critical Illness: Utility of a Panel of Genes and Molecules Involved in the Immunological Synapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'We will collect blood samples from the patients included in the study on ICU days 1, 3 and 5. We will measure gene expression (mRNA) and plasma levels of various elements involved in the immunological synapse.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-20', 'studyFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sex-related differences in the proportion of patients with a functional immunosuppression signature', 'timeFrame': '5 days', 'description': 'Number of patients with organ failure exhibiting an early transcriptomic signature denoting depression of the immunological synapse, grouped by sex category.'}, {'measure': 'Age-related differences in the proportion of patients with a functional immunosuppression signature', 'timeFrame': '5 days', 'description': 'Number of patients with organ failure exhibiting an early transcriptomic signature denoting depression of the immunological synapse, grouped by predefined age categories.'}, {'measure': 'Nutritional status-related differences in the proportion of patients with a functional immunosuppression signature', 'timeFrame': '5 days', 'description': 'Number of patients with organ failure exhibiting an early transcriptomic signature denoting depression of the immunological synapse, grouped by nutritional status on ICU admission.'}, {'measure': 'Frailty status-related differences in the proportion of patients with a functional immunosuppression signature', 'timeFrame': '5 days', 'description': 'Number of patients with organ failure exhibiting an early transcriptomic signature denoting depression of the immunological synapse, grouped by frailty status on ICU admission.'}, {'measure': 'Comorbid status-related differences in the proportion of patients with a functional immunosuppression signature', 'timeFrame': '5 days', 'description': 'Number of patients with organ failure exhibiting an early transcriptomic signature denoting depression of the immunological synapse, grouped by previous comorbidities.'}, {'measure': 'Diagnosis-related differences in the proportion of patients with a functional immunosuppression signature', 'timeFrame': '5 days', 'description': 'Number of patients with organ failure exhibiting an early transcriptomic signature denoting depression of the immunological synapse, grouped by diagnostic category on ICU admission.'}], 'primaryOutcomes': [{'measure': 'Proportion of patients with a functional immunosuppression signature', 'timeFrame': '5 days', 'description': 'Number of patients with organ failure exhibiting an early transcriptomic signature denoting depression of the immunological synapse.'}, {'measure': 'Mortality (28-day)', 'timeFrame': '28 days', 'description': 'Number of non-surviving patients in the groups with and without an early functional immunosuppression signature.'}, {'measure': 'Hospital-Acquired Infection (28-day)', 'timeFrame': '28 days', 'description': 'Number of patients developing hospital-acquired infections in the groups with and without an early functional immunosuppression signature.'}, {'measure': 'Organ Failure Resolution (28-day)', 'timeFrame': '28 days', 'description': 'Number of patients with organ failure resolution in the groups with and without an early functional immunosuppression signature.'}], 'secondaryOutcomes': [{'measure': 'Mortality (90-day)', 'timeFrame': '90 days', 'description': 'Number of non-surviving patients in the groups with and without an early functional immunosuppression signature.'}, {'measure': 'Hospital-Acquired Infection (90-day)', 'timeFrame': '90 days', 'description': 'Number of patients developing hospital-acquired infections in the groups with and without an early functional immunosuppression signature.'}, {'measure': 'Duration of hospitalization in the ICU', 'timeFrame': '90 days', 'description': 'Length of stay in the ICU in the groups with and without an early functional immunosuppression signature.'}, {'measure': 'Proportion of patients requiring organ support', 'timeFrame': '90 days', 'description': 'Number of patients who require organ support (mechanical ventilation, vasopressors, renal replacement therapy, extracorporeal membrane oxygenation,...) in the groups with and without an early functional immunosuppression signature.'}, {'measure': 'Proportion of patients with early cardiac dysfunction', 'timeFrame': '5 days', 'description': 'Number of patients who develop early cardiac dysfunction, as assessed by echocardiography, in the groups with and without an early functional immunosuppression signature.'}, {'measure': 'Proportion of patients with Herpesviridae reactivation', 'timeFrame': '90 days', 'description': 'Number of patients who develop Herpesviridae reactivation during ICU admission, in the groups with and without an early functional immunosuppression signature.'}, {'measure': 'Proportion of patients with ICU-related complications', 'timeFrame': '90 days', 'description': 'Number of patients who develop ICU-related complications during ICU admission, including ICU-acquired weakness, delirium, thrombosis or bleeding, in the groups with and without an early functional immunosuppression signature.'}, {'measure': 'Proportion of patients with post-intensive care syndrome', 'timeFrame': '90 days', 'description': 'Number of patients who develop post-intensive care syndrome, in the groups with and without an early functional immunosuppression signature.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical Illness'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': "Critical illnesses represent a significant physiological assault that triggers changes in the patient's immune system, resulting in an immunopotentiating response (systemic inflammatory response syndrome, SIRS) and an immunosuppressive response (compensatory anti-inflammatory response syndrome, CARS). The balance between SIRS and CARS is essential for the patient to return to a state of immune homeostasis and accelerate the healing process. However, when CARS is disproportionately intense, it leads to a state of immunoparalysis, which predisposes the patient to vulnerability to opportunistic infections, associated with a peak in late mortality. The majority of patients admitted to the ICU are considered immunocompetent. However, the investigators suspect that a significant proportion of them exhibit predominance of CARS and a state of functional immunosuppression. There is currently no diagnostic test to determine whether a patient is functionally immunocompetent at a specific point in time.\n\nThe goal of this observational study is to learn about the immune system dysfunction occurring in critical illness. The main questions it aims to answer are:\n\n* What is the prevalence of immune system dysfunction in critical illness?\n* Does immune system dysfunction affect multiple organ failure trajectory and mortality in critical illness?\n* Is immune system dysfunction related to an increased risk of opportunistic hospital-acquired infections in critical illness?\n* Is immune system dysfunction related to age, fragility, nutritional status or previous comorbidities in critical illness?\n\nTo answer these questions, the investigators will prospectively study a population of critically ill patients, defined by the presence of organ failure. The investigators will analyse a panel of genes and molecules involved in immunological synapse, using peripheral blood samples at different moments of the evolution of critical illness. Based on the analysis, the investigators will classify the patients' functional immune status and correlate it with the outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with any critical illness present in the ICU of the participating hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Failure of one or more organs, assessed by a Sequential Organ Failure Assessment Score (SOFA) ≥4 within the first 24 hours of admission to the Intensive Care Unit (ICU). At least one of the physiological systems involved must be in the category of organ failure and, therefore, score ≥3.\n* Informed consent to participate in the study.\n* Age equal to or greater than 18 years.\n\nExclusion Criteria:\n\n* Pharmacological immunosuppression within the 3 months prior to the current admission date, including treatment with corticosteroids, immunosuppressive drugs (conventional or biological), or chemotherapy.\n* Immunodeficiency.\n* Age under 18 years.\n* Absence of consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05954260', 'acronym': 'EFIMERO', 'briefTitle': 'Immune Dysfunction in Critical Illness: Utility of a Panel of Genes and Molecules Involved in the Immunological Synapse', 'organization': {'class': 'OTHER', 'fullName': 'University of Valladolid'}, 'officialTitle': 'Cuantificación de la Disfunción Inmunitaria Inducida Por la Enfermedad Crítica Mediante el Estudio de un Panel de Genes y Moléculas Implicadas en la Sinapsis Inmunológica y su Utilidad Pronóstica', 'orgStudyIdInfo': {'id': 'EFIMERO'}, 'secondaryIdInfos': [{'id': 'FEEC 2022/001', 'type': 'OTHER_GRANT', 'domain': 'SEMICYUC'}, {'id': 'GRS 2618/A/22', 'type': 'OTHER_GRANT', 'domain': 'Gerencia Regional de Salud de Castilla y León (SACYL)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'We will collect blood samples from the patients included in the study on ICU days 1, 3 and 5. We will measure gene expression (mRNA) and plasma levels of various elements involved in the immunological synapse.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47012', 'city': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'David Pérez-Torres, MD', 'role': 'CONTACT', 'email': 'inmunologia-criticos@saludcastillayleon.onmicrosoft.com', 'phone': '983420400', 'phoneExt': '83719'}], 'facility': 'Hospital Universitario Río Hortega', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'centralContacts': [{'name': 'David Pérez-Torres, MD', 'role': 'CONTACT', 'email': 'inmunologia-criticos@saludcastillayleon.onmicrosoft.com', 'phone': '983420400', 'phoneExt': '83719'}, {'name': 'Luis Mariano Tamayo-Lomas, MD, PhD', 'role': 'CONTACT', 'email': 'inmunologia-criticos@saludcastillayleon.onmicrosoft.com', 'phone': '983420400', 'phoneExt': '83719'}], 'overallOfficials': [{'name': 'David Pérez-Torres, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Río Hortega, Universidad de Valladolid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Pérez Torres', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital del Rio Hortega', 'class': 'OTHER'}, {'name': 'Sanidad de Castilla y León', 'class': 'OTHER'}, {'name': 'Instituto de Investigación Biomédica de Salamanca', 'class': 'OTHER'}, {'name': 'Fundación Española del Enfermo Crítico (FEEC)', 'class': 'UNKNOWN'}, {'name': 'Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Pérez Torres', 'investigatorAffiliation': 'University of Valladolid'}}}}