Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-03-03 @ 7:39 PM
Study NCT ID:
NCT02778633
Status:
UNKNOWN
Last Update Posted:
2018-01-25
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 Sepsis
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': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'Heart Rate'}, {'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'Mean Arterial Blood Pressure'}, {'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'Cardiac Index'}, {'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'Central Venous Pressure'}, {'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'Systemic Vascular Resistance'}, {'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'Pulse Pressure Variation'}, {'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'Pulmonary Vascular Permeability Index'}, {'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'Plethysmographic Oxygen Saturation'}, {'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'Delivery of Oxygen Index'}, {'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'Mechanical Ventilation Settings'}, {'measure': 'Secondary hemodynamic parameters', 'timeFrame': '1 hour', 'description': 'End-tidal CO2'}, {'measure': 'Secondary hemodynamic parameters', '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'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Septic patients on ICU', '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': 'NCT02778633', 'briefTitle': 'Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': 'Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Sepsis', 'orgStudyIdInfo': {'id': 'M12-1272'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis', 'description': 'Patients diagnosed with septic shock, admitted to the intensive care unit, with a good left ventricular ejection fraction without significant co-morbidity are highly eligible for this study. Patients must be equipped with a pulse-contour cardiac output (PICCO)-system with a central venous catheter which will be applied by the intensivist on admission.Patients will be subsequently connected to the hemodynamic monitoring device Navigator™. In those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'L.P.B. Meijs, MD', 'role': 'CONTACT', 'email': 'loek.meijs@catharinaziekenhuis.nl', 'phone': '0031-40-2399111'}, {'name': 'A.J.G.H. Bindels, PhD', 'role': 'CONTACT', 'email': 'Alex.Bindels@catharinaziekenhuis.nl', 'phone': '0031-40-2399111'}, {'name': 'Loek Meijs, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'A.J.G.H. Bindels, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'A. Roos, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}], 'centralContacts': [{'name': 'LPB Meijs, MD', 'role': 'CONTACT', 'email': 'Loek.Meijs@catharinaziekenhuis.nl', 'phone': '00312399111'}, {'name': 'LPB Meijs, MD', 'role': 'CONTACT', 'email': 'Loek.Meijs@catharinaziekenhuis.nl', 'phone': '0031-40-2399111'}], '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'}}}}