Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery
Free4Flow
An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study
3 other identifiers
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 15, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedAugust 16, 2011
August 1, 2011
1.3 years
August 15, 2011
August 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute change in transfer function (flap vascular resistance) after pressor infusion.
Post infusion (at 4 hours)
Secondary Outcomes (3)
Relative change in transfer function after pressor infusion compared with "normal" tissue.
Post infusion (at 4 hours)
Change in flap flow after pressor infusion
Post infusion (at 4 hours)
Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion.
Post infusion (at 4 hours)
Study Arms (1)
Pressors
EXPERIMENTALEpinephrine, Norepinephrine, Dobutamine, Dopexamine
Interventions
Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg
Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg
Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg
Eligibility Criteria
You may qualify if:
- Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit.
You may not qualify if:
- Pregnancy
- Weight \>100kg
- Contraindications to pressor infusions
- Overnight ventilation not indicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Related Publications (1)
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.
PMID: 22929242DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen R Watt-Smith, FDSRCS, MD
Oxford University Hospitals NHS Trust
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 15, 2011
First Posted
August 16, 2011
Study Start
October 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
August 16, 2011
Record last verified: 2011-08