Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-03 @ 7:20 AM
Study NCT ID:
NCT03621618
Status:
WITHDRAWN
Last Update Posted:
2025-11-18
First Post:
2018-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D025401', 'term': 'Echocardiography, Stress'}], 'ancestors': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'COVID-19 + not enough resources available', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2018-08-03', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Dynamic Arterial Elastance (Eadyn)', 'timeFrame': 'baseline and from 30-90 minutes after increase with 20% of vasoactive medication and haemodynamic stabilisation', 'description': 'display on the hemodynamic monitor'}], 'secondaryOutcomes': [{'measure': 'Eadyn estimation on haemodynamic monitor', 'timeFrame': 'from 30 to 90 minutes after increase with 20% of vasoactive medication', 'description': 'display on the hemodynamic monitor'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vasoactive medication', 'dynamic arterial elastance'], 'conditions': ['Sepsis', 'Cardiac Failure Acute']}, 'descriptionModule': {'briefSummary': 'The primary goal of the study is to determine Eadyn ( = PPV/SVV) as a functional measure of arterial load, in conjunction with other actual afterload indices, systemic vascular resistance and arterial elastance. A secondary aim is the assessment of the influences of vasopressors and inotropic drugs on Eadyn, as a parameter of ventriculo-arterial coupling.', 'detailedDescription': 'Assessment of the cardiovascular status and haemodynamics comprise directly or indirectly cardiac output, which is determined by left ventricular preload, contractility, afterload and heart rate. Various haemodynamic monitors have been introduced in anaesthesia and ICU practice, providing cardiac output either non-invasively or invasively. The combined use of arterial pressure monitoring with these devices provides insight not only in cardiac output but offers bedside assessment of most determinants of cardiovascular function. Both pulse pressure variation (PPV) and stroke volume variation (SVV) have been described as dynamic descriptors of fluid responsiveness, a measure allowing optimization of preloading conditions if haemodynamics show signals of insufficient perfusion.\n\nArterial load can be assessed based on a two-element Windkessel model with a static and dynamic component. The static part consists of a resistive element (systemic vascular resistance: SVR = (MAP/C0)\\*80, with MAP, mean arterial pressure; CO, cardiac output) and a pulsatile component (net arterial compliance C = SV/arterial pulse pressure with SV, stroke volume). Arterial elastance is considered being an integrative variable, associating both steady elements and heart rate (Ea = .9\\*SAP/SV with EA, arterial elastance; SAP, systolic arterial pressure). The dynamic component Eadyn is the ratio of PPV and SVV during a mechanical ventilator cycle, providing a functional assessment of ventriculo-arterial coupling.\n\nCombined use of arterial pressure tracing (or its non-invasive surrogate) and (non-) invasive stroke volume actually may provide an interesting framework for haemodynamic monitoring and subsequent optimization in many surgical, postoperative or ICU patients. This study aims to copy as good as possible the handling and the way of management as in a clinical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- ICU patients, treated/supported with noradrenalin or dobutamine.\n\nExclusion Criteria:\n\n* Septic shock\n* Aortic valve regurgitation and defect of septum\n* Severe aortic sclerosis, aortic prosthesis\n* Severe hypertension (MAP \\> 130 mmHg)\n* Cardiac arrhythmia\n* Tachycardia with a heart rate higher than 150 bpm\n* Age below 18 or above 75 y\n* Patient height below 120 cm (48") or above 230 cm (90")\n* Patient weight less than 30 kg (67 lbs.) or greater than 155 kg (341 lbs.)\n* Intra-aortic balloon pump'}, 'identificationModule': {'nctId': 'NCT03621618', 'briefTitle': 'Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Clinical Assessment of Arterial Dynamic Elastance in ICU Patients, Dependent on Inotropic or Vasopressor Drugs.', 'orgStudyIdInfo': {'id': 'Eadyn project 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'dobutamine', 'description': 'Cardiac failure', 'interventionNames': ['Diagnostic Test: dobutamine']}, {'type': 'OTHER', 'label': 'norepinephrine', 'description': 'Sepsis', 'interventionNames': ['Diagnostic Test: norepinephrine']}], 'interventions': [{'name': 'dobutamine', 'type': 'DIAGNOSTIC_TEST', 'description': 'evaluation of effects of dobutamine on dynamic arterial elastance in cardiac failure', 'armGroupLabels': ['dobutamine']}, {'name': 'norepinephrine', 'type': 'DIAGNOSTIC_TEST', 'description': 'evaluation of effects of norepinephrine on dynamic arterial elastance in sepsis', 'armGroupLabels': ['norepinephrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'overallOfficials': [{'name': 'Jan Poelaert, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}, {'name': 'Michel Vervoort, IR', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}