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Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery (Free4Flow)
This study has been completed.
Sponsor:
Oxford University Hospitals NHS Trust
Information provided by:
Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01418118
First received: August 15, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Oral Cancer Head and Neck Cancer Free Flap Hypotension | Drug: Epinephrine Drug: Norepinephrine Drug: Dobutamine Drug: Dopexamine | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
| Official Title: | An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study |
Resource links provided by NLM:
Further study details as provided by Oxford University Hospitals NHS Trust:
Primary Outcome Measures:
- Absolute change in transfer function (flap vascular resistance) after pressor infusion. [ Time Frame: Post infusion (at 4 hours) ]
Secondary Outcome Measures:
- Relative change in transfer function after pressor infusion compared with "normal" tissue. [ Time Frame: Post infusion (at 4 hours) ]
- Change in flap flow after pressor infusion [ Time Frame: Post infusion (at 4 hours) ]
- Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion. [ Time Frame: Post infusion (at 4 hours) ]
| Enrollment: | 25 |
| Study Start Date: | October 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pressors
Epinephrine, Norepinephrine, Dobutamine, Dopexamine
|
Drug: Epinephrine
0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg
Drug: Norepinephrine
Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg
Drug: Dobutamine
Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg
Drug: Dopexamine
Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg
|
Detailed Description:
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.
Twenty 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.
Eligibility| Ages Eligible for Study: | 17 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit.
Exclusion Criteria:
- Pregnancy
- Weight >100kg
- Contraindications to pressor infusions
- Overnight ventilation not indicated
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01418118
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418118
Locations
| United Kingdom | |
| John Radcliffe Hospital | |
| Oxford, Oxfordshire, United Kingdom, OX3 9DU | |
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
| Principal Investigator: | Stephen R Watt-Smith, FDSRCS, MD | Oxford University Hospitals NHS Trust |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mr SR Watt-Smith, Oxford Radcliffe Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01418118 History of Changes |
| Other Study ID Numbers: |
2008-000073-37 5579 2008 000073 37 ( EudraCT Number ) 08/H0606/31 ( Other Identifier: Oxfordshire Research Ethics Committee ) |
| Study First Received: | August 15, 2011 |
| Last Updated: | August 15, 2011 |
Keywords provided by Oxford University Hospitals NHS Trust:
|
noradrenaline norepinephrine epinephrine adrenaline dobutamine dopexamine inotrope |
pressor sympathomimetic free flap transplantation free tissue transfer microsurgery survival |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Hypotension Mouth Neoplasms Neoplasms by Site Neoplasms Vascular Diseases Cardiovascular Diseases Mouth Diseases Stomatognathic Diseases Epinephrine Racepinephrine Norepinephrine Dobutamine Dopexamine Epinephryl borate |
Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents |
ClinicalTrials.gov processed this record on September 21, 2017