Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00337805
Status:
COMPLETED
Last Update Posted:
2009-09-18
First Post:
2006-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-17', 'studyFirstSubmitDate': '2006-06-14', 'studyFirstSubmitQcDate': '2006-06-14', 'lastUpdatePostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of catecholamines at 8:00 the morning after surgery', 'timeFrame': 'first post operative day'}], 'secondaryOutcomes': [{'measure': 'Total use of catecholamines', 'timeFrame': 'Time in ICU'}, {'measure': 'Time in the ICU', 'timeFrame': 'Time in ICU'}, {'measure': 'Post-operative complications', 'timeFrame': 'Hospital stay or 28 days'}, {'measure': 'Bleeding', 'timeFrame': 'Hospital stay or 28 days'}, {'measure': 'Renal failure', 'timeFrame': 'Hospital stay or 28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colloid', 'crystalloid', 'hemodynamics', 'flow-directed', 'resuscitation'], 'conditions': ['Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '23159133', 'type': 'DERIVED', 'citation': 'Potter BJ, Deverenne B, Doucette S, Fergusson D, Magder S; Canadian Critical Care Trials Group. Cardiac output responses in a flow-driven protocol of resuscitation following cardiac surgery. J Crit Care. 2013 Jun;28(3):265-9. doi: 10.1016/j.jcrc.2012.09.008. Epub 2012 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. The hypothesis is that the use of a colloid solution will result in less use of catecholamines at 8:00 the morning following surgery. Secondary end-points include total use of catecholamines, time in the ICU, return to the ICU, and safety issues including bleeding and renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* status post cardiac surgery\n* pulmonary artery occlusion catheter in place\n* informed consent\n* morning case (must be out of OR by 2:00 PM\n\nExclusion Criteria:\n\n* excessive bleeding (\\> 200 cc/hr)\n* intraaortic balloon pump\n* refusal by treating team\n* emergency cases\n* patients with known adverse reactions to starch solutions'}, 'identificationModule': {'nctId': 'NCT00337805', 'briefTitle': 'Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'A Randomized Trial of Synthetic vs Normal Saline for the Flow-based Algorithmic Hemodynamic Resuscitation of Patients Post-cardiac Surgery', 'orgStudyIdInfo': {'id': 'BMA-04-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 colloid', 'description': 'Boluses of fluids are a pentastarch (up to 1000 ml)', 'interventionNames': ['Other: Pentaspan']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Crytalloid', 'description': 'Boluses are given as normal saline', 'interventionNames': ['Other: Pentaspan']}], 'interventions': [{'name': 'Pentaspan', 'type': 'OTHER', 'description': 'When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment', 'armGroupLabels': ['1 colloid', '2. Crytalloid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'sheldon magder, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr S Magder', 'oldOrganization': 'McGill University'}}}}