Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT01418118
Status:
COMPLETED
Last Update Posted:
2011-08-16
First Post:
2011-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D004280', 'term': 'Dobutamine'}, {'id': 'C046318', 'term': 'dopexamine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-15', 'studyFirstSubmitDate': '2011-08-15', 'studyFirstSubmitQcDate': '2011-08-15', 'lastUpdatePostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in transfer function (flap vascular resistance) after pressor infusion.', 'timeFrame': 'Post infusion (at 4 hours)'}], 'secondaryOutcomes': [{'measure': 'Relative change in transfer function after pressor infusion compared with "normal" tissue.', 'timeFrame': 'Post infusion (at 4 hours)'}, {'measure': 'Change in flap flow after pressor infusion', 'timeFrame': 'Post infusion (at 4 hours)'}, {'measure': 'Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion.', 'timeFrame': 'Post infusion (at 4 hours)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['noradrenaline', 'norepinephrine', 'epinephrine', 'adrenaline', 'dobutamine', 'dopexamine', 'inotrope', 'pressor', 'sympathomimetic', 'free flap', 'transplantation', 'free tissue transfer', 'microsurgery', 'survival'], 'conditions': ['Oral Cancer', 'Head and Neck Cancer', 'Free Flap', 'Hypotension']}, 'referencesModule': {'references': [{'pmid': '22929242', 'type': 'DERIVED', 'citation': 'Eley KA, Young JD, Watt-Smith SR. Epinephrine, norepinephrine, dobutamine, and dopexamine effects on free flap skin blood flow. Plast Reconstr Surg. 2012 Sep;130(3):564-570. doi: 10.1097/PRS.0b013e31825dbf73.'}]}, 'descriptionModule': {'briefSummary': 'Following surgery to remove tumours of the head and neck, patients undergo reconstruction with free flaps - tissue that is taken from elsewhere in the body and given a new blood supply by attaching it to vessels in the neck. Following this type of surgery, patients often need medication to maintain their blood pressure in the intensive care unit. The effect of these drugs on the transplanted tissues is unknown. This study investigates the effects of four commonly used drugs on free flap perfusion.', 'detailedDescription': 'The optimal sympathomimetic drug to support blood pressure without adverse vasoconstriction of free flap circulation remains unknown. This study examined the effects of four agents (epinephrine, norepinephrine, dobutamine and dopexamine) on free flaps following resection of head and neck cancer.\n\nTwenty five patients were recruited to the study. Each patient received an infusion of the four drugs in a random order with an intervening washout period between drugs, at four infusion rates. Continuous free flap skin blood flow monitoring was performed using laser Doppler velocimetry, with a second sensor on normal skin acting as a control. Global cardiovascular variables were monitored using the LiDCO Rapid pulse contour analysis system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit.\n\nExclusion Criteria:\n\n* Pregnancy\n* Weight \\>100kg\n* Contraindications to pressor infusions\n* Overnight ventilation not indicated'}, 'identificationModule': {'nctId': 'NCT01418118', 'acronym': 'Free4Flow', 'briefTitle': 'Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study', 'orgStudyIdInfo': {'id': '2008-000073-37 5579'}, 'secondaryIdInfos': [{'id': '2008 000073 37', 'type': 'EUDRACT_NUMBER'}, {'id': '08/H0606/31', 'type': 'OTHER', 'domain': 'Oxfordshire Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pressors', 'description': 'Epinephrine, Norepinephrine, Dobutamine, Dopexamine', 'interventionNames': ['Drug: Epinephrine', 'Drug: Norepinephrine', 'Drug: Dobutamine', 'Drug: Dopexamine']}], 'interventions': [{'name': 'Epinephrine', 'type': 'DRUG', 'description': '0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg', 'armGroupLabels': ['Pressors']}, {'name': 'Norepinephrine', 'type': 'DRUG', 'description': 'Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg', 'armGroupLabels': ['Pressors']}, {'name': 'Dobutamine', 'type': 'DRUG', 'description': 'Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg', 'armGroupLabels': ['Pressors']}, {'name': 'Dopexamine', 'type': 'DRUG', 'description': 'Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg', 'armGroupLabels': ['Pressors']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Stephen R Watt-Smith, FDSRCS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Hospitals NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mr SR Watt-Smith', 'oldOrganization': 'Oxford Radcliffe Hospitals NHS Trust'}}}}