Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-04 @ 7:02 PM
Study NCT ID:
NCT02661269
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-26', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2016-01-19', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in vessel density (mm/mm2) of the sublingual microcirculation between the two groups.', 'timeFrame': 'Cardiac surgery within 4 hours of ICU admittance, 1 offline total vessel density measurement, Septic patients +/- third day of ICU admittance, 1 offline total vessel density measurement.', 'description': 'With the Cytocam-IDF we make movies off the sublingual microcirculation for 6 seconds on 3 different spots, with offline analysis we calculate a mean total vessel density (total surface of vessels divided by total area surface).\n\nThe cardiac surgery group will be measured within 4 hours of admittance on the ICU. The septic patients group will be measured on the moment that the highest fluid balance during the ICU stay, so on the moment that there will be started with diuretics of renal replacement therapy to induce a negative fluid balance.'}], 'secondaryOutcomes': [{'measure': 'The correlation between a increasing fluid balance and the total vessel density in both groups separately.', 'timeFrame': 'The cumulative fluidbalance (L) will be noted at the same moment as the microcirculation movies are made, this will be the cumulative fluid balance as measured on the ICU.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Edema', 'Sepsis']}, 'descriptionModule': {'briefSummary': 'Can videomicroscopy of the sublingual microcirculation detect the increase in edema before peripheral edema will appear? By measuring the decrease in vesseldensity after strong positive fluid balances within septic patients versus euvolemic post-cardiac surgery patients. Measuring reactance and resistance (BIVA method) to determine volume status.\n\nPrimary outcome:\n\n\\- Total vessel density (TVD)\n\nSecondary outcome:\n\n* Fluid balance\n* BIVA measurements (reactance \\& resistance)', 'detailedDescription': "There are a lot of methods to determine if a patient is fluid-responsive, however a moment to stop fluid therapy is lacking. So the purpose of this study is to find a 'stop' moment for fluid therapy before peripheral edema will be present.\n\nWith sublingual measurements of the vessel density with the Cytocam-IDF, comparing the septic patients with fluid overload , euvolemic post-cardiac surgery patients at the arrival on the ICU and healthy volunteers we can determine if there is a decrease in vessel density during fluid loading.\n\nTo give a accurate view on fluid overload we include a bio-impedance measurement of reactance and resistance. Fluid balances are recorded very accurate by our electronic patient record."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ICU population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* after cardiac surgery\n* septic patient with a fluid balance of 4L +\n\nExclusion Criteria:\n\n* recent maxillofacial surgery'}, 'identificationModule': {'nctId': 'NCT02661269', 'briefTitle': 'Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity', 'organization': {'class': 'OTHER', 'fullName': 'Frisius Medisch Centrum'}, 'officialTitle': 'Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity', 'orgStudyIdInfo': {'id': 'nWMO 127'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Septic patients', 'description': 'Septic patients with fluid overload (fluid balance + 4 L)', 'interventionNames': ['Device: Videomicroscopy of the sublingual microcirculation', 'Device: Bio-impedance measurements.']}, {'label': 'Post-cardiac surgery patients', 'description': 'Patients after cardiac surgery, at arrival on ICU.', 'interventionNames': ['Device: Videomicroscopy of the sublingual microcirculation', 'Device: Bio-impedance measurements.']}], 'interventions': [{'name': 'Videomicroscopy of the sublingual microcirculation', 'type': 'DEVICE', 'description': 'Measuring total vessel density with the Cytocam-IDF camera.', 'armGroupLabels': ['Post-cardiac surgery patients', 'Septic patients']}, {'name': 'Bio-impedance measurements.', 'type': 'DEVICE', 'description': 'measuring resistance and reactance with the BIVA method.', 'armGroupLabels': ['Post-cardiac surgery patients', 'Septic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8901 BR', 'city': 'Leeuwarden', 'state': 'Provincie Friesland', 'country': 'Netherlands', 'facility': 'Medical Centre Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}], 'overallOfficials': [{'name': 'E.C. Boerma, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Frisius Medisch Centrum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frisius Medisch Centrum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gerke Veenstra', 'investigatorAffiliation': 'Frisius Medisch Centrum'}}}}