Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT03410069
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2018-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-07-23', 'releaseDate': '2019-05-22'}], 'estimatedResultsFirstSubmitDate': '2019-05-22'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2018-01-12', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of complications', 'timeFrame': '28 days', 'description': 'Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.'}], 'secondaryOutcomes': [{'measure': 'Applicability of the procedure', 'timeFrame': '28 days', 'description': 'Evaluation of applicability (compared to a standard Foley catheter): questionnaire for the nurse and/or the physician.'}, {'measure': 'Signal acquisition', 'timeFrame': '28 days', 'description': 'Duration of useable signal acquisition (duration of perfusion index computation)'}, {'measure': 'Effect of the position of the sensor', 'timeFrame': '28 days', 'description': 'Quality of signal according to sensor position (proximal/distal)'}, {'measure': 'Quality of the signal', 'timeFrame': '28 days', 'description': 'Assessment of signal Quality, including Signal-to-noise ratio'}, {'measure': 'Evolution of mean arterial pressure', 'timeFrame': '28 days', 'description': 'Measures of hemodynamic /metabolic parameters: mean arterial pressure (MAP)'}, {'measure': 'Evolution of SpO2', 'timeFrame': '28 days', 'description': 'Measures of hemodynamic /metabolic parameters: SpO2'}, {'measure': 'Evolution of SVO2', 'timeFrame': '28 days', 'description': 'Measures of hemodynamic /metabolic parameters: SVO2'}, {'measure': 'Evolution of lactates dosages', 'timeFrame': '28 days', 'description': 'Measures of hemodynamic /metabolic parameters: lactactes'}, {'measure': 'Evolution of cardiac outputs', 'timeFrame': '28 days', 'description': 'Measures of hemodynamic /metabolic parameters: cardiac output'}, {'measure': 'Evolution of central venous pressure', 'timeFrame': '28 days', 'description': 'Measures of hemodynamic /metabolic parameters: central venous pressure (CVP)'}, {'measure': 'Evolution of catecholamine infusions levels', 'timeFrame': '28 days', 'description': 'Measures of hemodynamic /metabolic parameters: catecholamine infusions levels'}, {'measure': 'Rate of resuscitation events', 'timeFrame': '28 days', 'description': 'Measures of hemodynamic or metabolic parameters: resuscitation events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High-risk Surgical Patients']}, 'referencesModule': {'references': [{'pmid': '31691897', 'type': 'DERIVED', 'citation': 'Depret F, Leone M, Duclos G, Futier E, Montagne M, Legrand M, Allaouchiche B. Monitoring tissue perfusion: a pilot clinical feasibility and safety study of a urethral photoplethysmography-derived perfusion device in high-risk patients. J Clin Monit Comput. 2020 Oct;34(5):961-969. doi: 10.1007/s10877-019-00414-9. Epub 2019 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'Circulatory shock is defined as an imbalance between oxygen supply and/or impaired oxygen use to maintain organ function. With growing evidence of lack of correlation between macro- and micro-circulation, use of "Whole Body" markers such as blood pressure (BP) or Lactates are often insufficient to assess the severity of the oxygen debt and/or tissue hypoperfusion. Thus, an approach incorporating tissue-perfusion based endpoints would represent a significant step up to guide optimal resuscitation of critically-ill patients and to reduce complications in high-risk surgery.\n\nCurrent monitoring techniques, that complement systemic hemodynamics by focusing on regional perfusion, still lack the required user-friendliness and/or clinical relevance to be routinely used at bedside. Therefore, assessment of the adequacy of tissue perfusion and oxygenation is suboptimal, and implementation of the above-mentioned approaches of resuscitation is still a challenge.\n\nUrethral perfusion is likely to be early and significantly impaired during low-flow states and thus represents a good "candidate" as a surrogate site to assess the perfusion of visceral organs. Besides, urethral mucosa can be investigated in a less invasive and simpler manner than "deeper" organs. Nowadays, no practical methods or devices are available to monitor perfusion in the pelvic area. Thus, recent development of a new monitoring device of urethral perfusion could fill this need and enable enhanced management of patients in Intensive Care Units (ICU) and Operating Rooms (OR).\n\nThe device consists of a modified Foley catheter equipped with a photoplethysmographic sensor: the IKORUS UP probe.\n\nThe probe will be used by intensivists or anesthesiologists on high-risk surgical patients, i.e. patients with comorbidities undergoing major vascular, thoracic and/or abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. 18 years of age or more,\n2. Male or female,\n3. High-Risk surgical patient,\n4. Life expectancy expected to exceed 72 hours,\n5. Willing to participate and signed informed consent,\n6. Affiliation to the French social security system.\n\nNon inclusion criteria:\n\n1. Pregnant or lactating woman,\n2. History of recent urological surgery (bladder surgery, prostate surgery…),\n3. Known stricture or "impossible insertion" last hospitalization,\n4. Traumatic injury to the lower urinary tract,\n5. History of radiotherapy of pelvic or genital area,\n6. Genital malformation (Hypospadias…).'}, 'identificationModule': {'nctId': 'NCT03410069', 'acronym': 'STEP UP', 'briefTitle': 'Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Perfusion Diagnostics'}, 'officialTitle': 'Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients: a Pilot Clinical Study To Evaluate the aPplicability and the Safety of Urethral Perfusion Measurement With the IKORUS System', 'orgStudyIdInfo': {'id': '2017-A03466-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IKORUS UP', 'interventionNames': ['Device: IKORUS UP system']}], 'interventions': [{'name': 'IKORUS UP system', 'type': 'DEVICE', 'description': 'Continuous assessment of the urethral microcirculation', 'armGroupLabels': ['IKORUS UP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '69310', 'city': 'Lyon', 'country': 'France', 'facility': 'Lyon Sud Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Nord Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hospital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Bernard Allaouchiche, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Perfusion Diagnostics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CEISO', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-05-22', 'type': 'RELEASE'}, {'date': '2019-07-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Advanced Perfusion Diagnostics'}}}}