Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-02-21 @ 12:14 AM
Study NCT ID:
NCT01613859
Status:
COMPLETED
Last Update Posted:
2016-05-27
First Post:
2012-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Cardiac Output and Intravascular Volume Status in Children Using COstatus (SH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-25', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-06-04', 'lastUpdatePostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing CO and other clinical markers in Pediatric ICU', 'timeFrame': 'During patients stay in ICU with insitu catheter, expected average 3-4 days', 'description': 'The objective of this study is to see if the CO measurements obtained with COstatus show a linear correlation with all other indirect and invasive methods currently used to measure CO (within acceptable range) and with the CO measured by thermodilution in the cardiac catheterization lab.'}]}, 'conditionsModule': {'conditions': ['Intensive Care']}, 'referencesModule': {'references': [{'pmid': '18496416', 'type': 'BACKGROUND', 'citation': 'Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.'}]}, 'descriptionModule': {'briefSummary': 'Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is an integral part of hemodynamic monitoring of critically ill patients whether it is done directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies to support the cardiovascular system in critically ill children with multi organ dysfunction. Because of the side effects involved in measuring cardiac output directly, intensive monitoring of patients is currently limited to an integrated assessment of tissue perfusion, oxygen delivery and cellular health both at regional and global levels. Currently available methods of measuring CO have their limitations and complications, and are not used routinely for bedside monitoring. Therefore, the investigators propose to use a newly developed method, termed COstatus for the monitoring of CO in patients admitted to PICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric Patients (under 21 years of age) in the ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients under 21 years\n2. Presence of compensated or decompensated shock irrespective of etiology\n3. Presence of an existing peripheral arterial and central venous catheters\n\nExclusion Criteria:\n\n1\\. Patients allergic to heparin'}, 'identificationModule': {'nctId': 'NCT01613859', 'briefTitle': 'Measurement of Cardiac Output and Intravascular Volume Status in Children Using COstatus (SH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Transonic Systems Inc.'}, 'officialTitle': 'Measurement of Cardiac Output and Intravascular Volume Status in Critically Ill Children Using an Ultrasound Dilution Method (COstatus)', 'orgStudyIdInfo': {'id': 'TSI-G-COstatus-12A-H'}, 'secondaryIdInfos': [{'id': 'R44HL061994', 'link': 'https://reporter.nih.gov/quickSearch/R44HL061994', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': "Shands Children's Hospital, University of Florida", 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Jai Udassi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shands Children's Hospital, University of Florida"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Transonic Systems Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}