Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-29 @ 7:07 AM
Study NCT ID:
NCT01227304
Status:
UNKNOWN
Last Update Posted:
2010-10-25
First Post:
2010-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMOOCH - Small Volume Challenges to Predict Volume Responsiveness: Prospective Interventional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-22', 'studyFirstSubmitDate': '2010-10-21', 'studyFirstSubmitQcDate': '2010-10-22', 'lastUpdatePostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction of volume responsiveness defined as an increase in Cardiac Index of ≥ 15% after transpulmonary thermodilution measurement of 15 minutes', 'timeFrame': '15 minutes after start of infusion'}, {'measure': 'Prediction of volume responsiveness defined as an increase in Cardiac Index of ≥ 15% after transpulmonary thermodilution measurement of 30 minutes', 'timeFrame': '30 minutes after start of infusion'}], 'secondaryOutcomes': [{'measure': 'Predictive capabilities of Cardiac Index (measured by pulse contour)', 'timeFrame': 'within 30 minutes after start of infusion'}, {'measure': 'Comparison of global enddiastolic volume index to baseline values', 'timeFrame': '30 minutes after start of infusion'}, {'measure': 'Comparison of central venous pressure levels to baseline values', 'timeFrame': '30 minutes after start of infusion'}]}, 'conditionsModule': {'conditions': ['Prediction of Volume Responsiveness']}, 'descriptionModule': {'briefSummary': '* test for volume responsiveness\n* PiCCO-guided infusion over a pre-defined period of time'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are equipped with PiCCO monitoring independently to the study.\n* One criteria of decreased usefulness of the parameters of preload/volume responsiveness available using the PiCCO device:\n\n 1. Femoral access of the central venous catheter precluding application of the normal ranges of global enddiastolic volume index and central venous pressure.\n 2. Absence of sinus rhythm and/or controlled ventilation precluding the use of stroke volume variation.\n 3. Evidence of increased intraabdominal pressure which is known to further reduce the usefulness of central venous pressure.\n 4. Contradictory suggestions by stroke volume variation and global enddiastolic volume index.\n 5. Intolerance of passive leg raising.\n 6. Absence of therapeutic alternatives to volume resuscitation.\n\nExclusion Criteria:\n\n* Extravascular volume-over plus: global enddiastolic volume index \\> 1000ml/sqm\n* Pulmonary edema: extravascular lungwater index \\> 20ml/kg\n* Cardiogenic shock without volume deficiency (cardiac index \\<2L/min; global enddiastolic volume index \\> 850ml/sqm)'}, 'identificationModule': {'nctId': 'NCT01227304', 'acronym': 'SMOOCH', 'briefTitle': 'SMOOCH - Small Volume Challenges to Predict Volume Responsiveness: Prospective Interventional Study', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'orgStudyIdInfo': {'id': 'SMOOCH-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test of volume responsiveness using crystalloids', 'interventionNames': ['Device: PiCCO-parameter-guided volume challenge']}], 'interventions': [{'name': 'PiCCO-parameter-guided volume challenge', 'type': 'DEVICE', 'description': 'Infusion of 7ml/kg crystalloid over 30 minutes, Performing transpulmonary thermodilutions after 0min, 15min and 30min. Recording of pulse contour cardiac index, heart rate and mean arterial pressure after 5, 10, 15, 20, 25 and 30min. Catecholamines are kept stable over the 30min period.', 'armGroupLabels': ['Test of volume responsiveness using crystalloids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Wolfgang Huber, MD', 'role': 'CONTACT', 'email': 'wolfgang.huber@lrz.tum.de', 'phone': '+49-89-4140-2214'}, {'name': 'Wolfgang Huber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Josef Hoellthaler, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrea Herrmann', 'role': 'SUB_INVESTIGATOR'}], 'facility': '2nd Medical Department, Klinikum rechts der Isar', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wolfgang Huber', 'oldOrganization': 'Klinikumr rechts der Isar'}}}}