Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-28 @ 9:45 PM
Study NCT ID:
NCT02778620
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2016-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness in Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016534', 'term': 'Cardiac Output, High'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Heart Rate', 'timeFrame': '1 hour', 'description': 'Heart Rate in bpm'}, {'measure': 'MAP', 'timeFrame': '1 hour', 'description': 'Mean Arterial Blood Pressure'}, {'measure': 'CI', 'timeFrame': '1 hour', 'description': 'Cardiac Index'}, {'measure': 'CVP', 'timeFrame': '1 hour', 'description': 'Central Venous Pressure'}, {'measure': 'SVR', 'timeFrame': '1 hour', 'description': 'Systemic Vascular Resistance'}, {'measure': 'PPV', 'timeFrame': '1 hour', 'description': 'Pulse Pressure Variation'}, {'measure': 'PVPI', 'timeFrame': '1 hour', 'description': 'Pulmonary Vascular Permeability Index'}, {'measure': 'pO2', 'timeFrame': '1 hour', 'description': 'Plethysmographic Oxygen Saturation'}, {'measure': 'DO2I', 'timeFrame': '1 hour', 'description': 'Delivery of Oxygen Index'}, {'measure': 'Ventilation', 'timeFrame': '1 hour', 'description': 'Mechanical Ventilation Settings'}, {'measure': 'etCO2', 'timeFrame': '1 hour', 'description': 'End-tidal CO2'}, {'measure': 'Temp perif', 'timeFrame': '1 hour', 'description': 'Peripheral Temperature'}], 'primaryOutcomes': [{'measure': 'Mean systemic filling pressure (Pms)', 'timeFrame': '1 hour', 'description': 'An increase in mean systemic filling pressure after (self)volume-challenge indicating volume responsiveness of the patient'}], 'secondaryOutcomes': [{'measure': 'Heart performance (eH)', 'timeFrame': '1 hour', 'description': 'Quotient of driving pressure of venous return in mmHg'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Volume responsiveness mean systemic filling pressure'], 'conditions': ['Cardiac Output, High']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.', 'detailedDescription': 'The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need to adequate determination of intravascular volume status and therefore reliable predictors of fluid responsiveness are highly relevant. However, in determining the fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. Passive leg raising (PLR) represents a "self-volume challenge" that predicts preload responsiveness and the transient hemodynamic changes on venous return can be directly monitored in ventilated patients, provided that there is an intact circulation, in order to test the amount of volume responsiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Post-aortic valve replacement patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be older than 18 years, and must be equipped with a pulse-contour cardiac output system with a central venous catheter.\n* Patients will be subsequently connected to the hemodynamic monitoring device Navigator™.\n* In those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed.\n\nExclusion Criteria:\n\n* Patients with assist devices (e.g. intra aortic balloon pump, Impella®, ECMO), patients with arrhythmias (either atrial of ventricular) will be excluded from the study.\n* Also, patients with inguinal impairment or contraindications for a passive leg raising will be excluded (such as deep venous thrombosis or elastic compression stocking), head trauma, an increase intra-abdominal pressure suspected by clinical context and examination as well as patients with absolute contraindications for fluid challenge.'}, 'identificationModule': {'nctId': 'NCT02778620', 'briefTitle': 'Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness in Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': 'Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Aortic Valve Replacement', 'orgStudyIdInfo': {'id': 'M12-1270'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aortic Valve Replacement', 'description': 'Post Anaesthetic Care Unit (PACU) patients treated with aortic valve replacement (AVR) are highly eligible for this study.These are patients with an indication for fast track treatment (PACU) post-cardiac surgery with a good left ventricular ejection fraction without significant co-morbidity. The final decision for PACU-classification is taken by the responsible anaesthesiologist and intensivist in close collaboration with the cardiothoracic surgeon performing the operation, as well as the cardiologist.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}], 'overallOfficials': [{'name': 'Jan Bakker, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No, data remain anonymized within hospital and property of PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erasmus Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD-candidate Intensive Care Unit / resident cardiology', 'investigatorFullName': 'L.P.B. Meijs', 'investigatorAffiliation': 'Catharina Ziekenhuis Eindhoven'}}}}