Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT07298720
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CO Response', 'timeFrame': 'During procedure', 'description': 'The relative increase in % of the CO, from baseline during the PLR (at 60-120 seconds within the maneuver), will be calculated. Those subjects with a relative increase equal to or above 10% will be classified as CO-responders to the PLR. On the other hand, if the increase in CO during the PLR is below 10%, subjects will be classified as non-responders.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluid-responsiveness', 'Hemodynamic monitoring', 'Preload-responsiveness', 'Cardiac output'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': "Proof-of-concept observational study including ICU patients undergoing a PLR maneuver. Local microvasculature will be assessed with the hDOS platform on the brachioradialis muscle, deriving the microvascular blood flow index (BFI) and tissue oxygen saturation (StO2). CO will be assessed via an invasive hemodynamic monitor based on pulse waveform analysis through the patient's arterial line. The correlation over time between CO and microvascular parameters, and the ability of microvascular variables for predicting a positive CO response (increase \\> 10%) will be assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients with their blood pressure invasively monitored through an arterial line', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive blood pressure monitoring through an arterial line\n\nExclusion Criteria:\n\n* Patients with suspected pregnancy\n* Intra-abdominal hypertension\n* Elevated intracranial pressure'}, 'identificationModule': {'nctId': 'NCT07298720', 'acronym': 'hDOS-CO', 'briefTitle': 'Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle', 'orgStudyIdInfo': {'id': 'CEIm 2024/3001'}, 'secondaryIdInfos': [{'id': 'INN2024003', 'type': 'OTHER_GRANT', 'domain': "Institut d'Investigació i Innovació Parc Taulí"}, {'id': 'CIR2023014', 'type': 'OTHER_GRANT', 'domain': "Institut d'Investigació i Innovació Parc Taulí"}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critical care patient', 'description': 'Critical care patients with their blood pressure invasively monitored through an arterial line', 'interventionNames': ['Other: Passive Leg Raising maneuver']}], 'interventions': [{'name': 'Passive Leg Raising maneuver', 'type': 'OTHER', 'description': 'The PLR will be performed using automatic bed adjustment: Starting from a semi-recumbent position, the lower limbs will be elevated to a 45° angle while the trunk will be moved from semi-recumbent to supine. After three minutes, subjects will be returned to the initial semi-recumbent position.', 'armGroupLabels': ['Critical care patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Spain/ Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jaume Mesquida Senior Clinical Researcher, MD', 'role': 'CONTACT', 'email': 'jmesquida@tauli.cat', 'phone': '+34 616722287'}], 'facility': 'Parc Taulí Hospital Universitari', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'Jaume Mesquida Senior Clinical Researcher, MD', 'role': 'CONTACT', 'email': 'jmesquida@tauli.cat', 'phone': '+34 616722287'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut de Ciències Fotòniques (ICFO)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Clinical Researcher', 'investigatorFullName': 'Jaume Mesquida', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}