Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-26 @ 6:47 AM
Study NCT ID:
NCT03395951
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2018-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D016638', 'term': 'Critical Illness'}], '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'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004232', 'term': 'Diuretics'}], 'ancestors': [{'id': 'D045283', 'term': 'Natriuretic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2015-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2018-01-01', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean systemic filling pressure (mmHg)', 'timeFrame': 'Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours', 'description': 'Decrease or increase in mean systemic filling pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device'}], 'secondaryOutcomes': [{'measure': 'Change in cardiac index (L/min/m2)', 'timeFrame': 'Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours', 'description': 'Decrease/increase in cardiac index measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device'}, {'measure': 'Change in mean arterial pressure (mmHg)', 'timeFrame': 'Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours', 'description': 'Decrease/increase in mean arterial pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device'}, {'measure': 'Change in central venous pressure (mmHg)', 'timeFrame': 'Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours', 'description': 'Decrease/increase in central venous pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device'}, {'measure': 'Change in pressure for venous return (mmHg)', 'timeFrame': 'Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours', 'description': 'Decrease/increase in pressure for venous return measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device'}, {'measure': 'Change in resistance to venous return (dynes⋅sec⋅cm-5)', 'timeFrame': 'Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours', 'description': 'Decrease/increase in resistance te venous return measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device'}, {'measure': 'Change in systemic vascular resistance index (dynes⋅sec⋅cm-5)', 'timeFrame': 'Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours', 'description': 'Decrease/increase in systemic vascular resistance index measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device'}, {'measure': 'Change in venous return index (L/min/m2)', 'timeFrame': 'Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours', 'description': 'Decrease/increase in venous return index measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device'}, {'measure': 'Change in heart rate (bpm)', 'timeFrame': 'Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours', 'description': 'Decrease/increase in heart rate measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device'}, {'measure': 'Change in extra vascular lung water index (mL/kg)', 'timeFrame': 'Baseline and after 24 hours', 'description': 'Decrease/increase in extra vascular lung water index measured with continuous cardiac output monitoring PiCCO(R) device'}, {'measure': 'Change in global end diastolic volume index (mL/m2)', 'timeFrame': 'Baseline and after 24 hours', 'description': 'Decrease/increase in global end diastolic volume index measured with continuous cardiac output monitoring PiCCO(R) device'}, {'measure': 'Change in intrathoracic blood volume index (mL/m2)', 'timeFrame': 'Baseline and after 24 hours', 'description': 'Decrease/increase in intrathoracic blood volume index measured with continuous cardiac output monitoring PiCCO(R) device'}, {'measure': 'Creatinin (renal function) mmol/L', 'timeFrame': 'Baseline and after 24 hours', 'description': 'Increase/decrease in creatinin (standard blood withdrawal within standard ICU treatment)'}, {'measure': 'Electrolyte balance (potassium, sodium levels) (mmol/L)', 'timeFrame': 'Baseline and after 24 hours', 'description': 'Increase/decrease in electrolyte balance (potassium, sodium levels) (standard blood withdrawal within standard ICU treatment)'}, {'measure': 'Diuresis per hour (mL/hour)', 'timeFrame': 'Baseline, 1 hour, 2 hours and after 24 hours', 'description': 'Increase/decrease in diuresis (standardly measured within standard ICU treatment)'}, {'measure': 'Body weight (kg)', 'timeFrame': 'Baseline and after 24 hours', 'description': 'Increase/decrease in body weight (standardly measured within standard ICU treatment)'}, {'measure': 'Fluid balance (mL)', 'timeFrame': 'Baseline and after 24 hours', 'description': 'Increase/decrease in fluid balance (mL) (standardly measured within standard ICU treatment)'}, {'measure': 'Change in cardiac performance (eH) (dimensionless)', 'timeFrame': 'Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours', 'description': 'Increase/decrease in cardiac performance (eH)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mean Systemic Filling Pressure', 'Diuretics', 'Pressure for venous return', 'Fluid Balance', 'De-escalation fluid therapy', 'De-resuscitation', 'Guyton', 'Guytonian Approach', 'Furosemide', 'Cardiac Output', 'Cardiac Index'], 'conditions': ['Sepsis', 'Heart Failure', 'Heart Diseases', 'Septic Shock', 'Surgery', 'Critically Ill']}, 'descriptionModule': {'briefSummary': 'Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy.', 'detailedDescription': 'Rationale: 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 for adequate determination of intravascular volume status. However, in determining the intravascular 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.\n\nPositive fluid balance and /or substantial weight gain in critically ill patients is a common problem in the intensive care unit (ICU), potentially associated with a poor outcome. This problem, in association with hemodynamic instability and increase of creatinin, ureum and sodium, may lead to peripheral edema. Furosemide, a loop diuretic, is frequently administered to critically ill patients to increase urine output and to relieve edema.\n\nObjective: Observing changes in Pms during continuous furosemide administration.\n\nStudy design: Prospective, observational study Study population: Patients with a PICCO® system with a positive fluid balance and / or substantial weight gain and therefore with a clinical indication for diuretic therapy.\n\nIntervention: Continuous furosemide administration. Main study parameters/endpoints: Pms measured at baseline, changes in Pms during continuous furosemide administration.\n\nAdverse events: No risks involved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients with a clinical indication for treatment with intravenous diuretics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be at least 18 years\n* PiCCO in situ (cardiac output device applied in light of clinical treatment)\n* CVL in situ\n* Clinical indication for continuous furosemide administration\n\nExclusion Criteria:\n\n* Patients younger then 18 years\n* Patients without PiCCO\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT03395951', 'briefTitle': 'Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': 'Clinical Observation of Mean Systemic Filling Pressure in Critical Care Patients With Continuous Diuretics Administration', 'orgStudyIdInfo': {'id': 'n-WMO 2014-43'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diuretics', 'type': 'DRUG', 'otherNames': ['Diuretic therapy'], 'description': 'Observation of hemodynamics during diuretics treatment within clinical indication.'}]}, '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': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Years', 'ipdSharing': 'YES', 'description': 'Under negotiable conditions sharing of data can be discussed.', 'accessCriteria': 'Negotiable'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erasmus Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator L.P.B. Meijs, MD, PhD-candidate Intensive Care Unit / resident cardiology', 'investigatorFullName': 'L.P.B. Meijs', 'investigatorAffiliation': 'Catharina Ziekenhuis Eindhoven'}}}}