Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-03-01 @ 7:33 AM
Study NCT ID:
NCT01521195
Status:
COMPLETED
Last Update Posted:
2021-07-23
First Post:
2012-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxygen Consumption In Critically Ill Children
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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-22', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-25', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen consumption (VO2)', 'timeFrame': 'Baseline', 'description': 'VO2 will be measured using a mass spectrometer as this is the gold standard.'}, {'measure': 'Oxygen consumption (VO2)', 'timeFrame': '30min', 'description': 'VO2 will be measured using a mass spectrometer as this is the gold standard.'}, {'measure': 'Oxygen consumption (VO2)', 'timeFrame': '60min', 'description': 'VO2 will be measured using a mass spectrometer as this is the gold standard.'}, {'measure': 'Oxygen consumption (VO2)', 'timeFrame': '90min', 'description': 'VO2 will be measured using a mass spectrometer as this is the gold standard.'}], 'secondaryOutcomes': [{'measure': 'Arterial serum lactate level', 'timeFrame': 'Baseline, 30min, 60min, 90min'}, {'measure': 'Oxygen extraction ratio.', 'timeFrame': 'Baseline, 30min, 60min, 90min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric', 'ECMO', 'extracorporeal blood flow', 'VO2'], 'conditions': ['Extracorporeal Membrane Oxygenation']}, 'referencesModule': {'references': [{'pmid': '26371816', 'type': 'RESULT', 'citation': 'Tosoni A, La Rotta G, Breatnach C, Anand V, Foreman C, Davidson L, Redington AN, Kavanagh BP. Oxygen Delivery and Consumption Are Independent: Evidence from Venoarterial Extracorporeal Membrane Oxygenation in Resuscitated Children. Am J Respir Crit Care Med. 2015 Sep 15;192(6):765-7. doi: 10.1164/rccm.201502-0267LE. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to examine the relationship between DO2 and VO2 in critically ill patients requiring an Extracorporeal Membrane Oxygenation (ECMO) machine. This machine can provide complete support of heart and lung function. In so doing, the investigators will be able to avoid physiologic coupling by increasing DO2 mechanically, by increasing blood flow through the ECMO circuit.\n\nNull Hypothesis:\n\nIncreased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is not associated with an increase in oxygen consumption.\n\nAlternate Hypothesis:\n\nIncreased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is associated with an increase in oxygen consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the Critical Care Unit on veno-arterial ECMO.\n* Hemodynamic stability established, as adjudged by the treating CCU staff physician.\n* Informed consent by parent or legal guardian.\n* Approval by treating CCU staff physician to approach parents/guardians for consent process at any given time.\n\nExclusion Criteria:\n\n* Patients in the Critical Care Unit on veno-venous (VV) ECMO.\n* Inability to tolerate study period without red cell transfusion.\n* Presence of a large leak around the endotracheal tube (\\> 10% tidal volume).\n* Patients requiring \\> 70 % FiO2 at the time of potential enrollment.\n* Parent or legal guardian refuse consent.'}, 'identificationModule': {'nctId': 'NCT01521195', 'briefTitle': 'Oxygen Consumption In Critically Ill Children', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'A Pilot Study of the Relationship Between Oxygen Delivery and Consumption During Extracorporeal Membrane Oxygenation.', 'orgStudyIdInfo': {'id': '1000017147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients on veno-arterial (VA) ECMO', 'interventionNames': ['Device: Extracorporeal blood flow via ECMO machine']}], 'interventions': [{'name': 'Extracorporeal blood flow via ECMO machine', 'type': 'DEVICE', 'description': 'Extracorporeal Membrane Oxygenation (ECMO) machine can provide complete support of heart and lung function.\n\nExtracorporeal blood flow will be given at baseline rate, increased by 25% and decreased by 25%', 'armGroupLabels': ['Patients on veno-arterial (VA) ECMO']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5V1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Brian Kavanagh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}