Oral CancerPhase 4Free4FlowNCT01418118
Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery
A Phase 4 study testing Epinephrine, Norepinephrine and Dobutamine in people with Oral Cancer and Head and Neck Cancer, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Oral Cancer, Head and Neck Cancer, Free Flap
- What is being tested?
- Epinephrine, Norepinephrine and Dobutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2008to Feb 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit.
Who cannot join
- Pregnancy
- Weight >100kg
- Contraindications to pressor infusions
- Overnight ventilation not indicated
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study
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.
Read the 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.
- Conditions
- Oral Cancer, Head and Neck Cancer, Free Flap, Hypotension
- Being tested
- Epinephrine, Norepinephrine, Dobutamine, Dopexamine
- Keywords
- noradrenaline, norepinephrine, epinephrine, adrenaline, dobutamine, dopexamine, inotrope, pressor, sympathomimetic, free flap, transplantation, free tissue transfer, microsurgery, survival
- Medical subject headings
- Mouth Neoplasms, Head and Neck Neoplasms, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg
NorepinephrineDrug
Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg
DobutamineDrug
Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg
DopexamineDrug
Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg
| Study group | Role | What they receive |
|---|---|---|
| Pressors | Experimental | Epinephrine, Norepinephrine, Dobutamine, Dopexamine Receives: Drug: Epinephrine; Drug: Norepinephrine; Drug: Dobutamine; Drug: Dopexamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in transfer function (flap vascular resistance) after pressor infusion.
Measured: Post infusion (at 4 hours)
Secondary outcomes (3)
Relative change in transfer function after pressor infusion compared with "normal" tissue.
Measured: Post infusion (at 4 hours)
Change in flap flow after pressor infusion
Measured: Post infusion (at 4 hours)
Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion.
Measured: Post infusion (at 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startOct 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Stephen R Watt-Smith, FDSRCS, MD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418118
- Sponsor's protocol ID
- 2008-000073-37 5579
- Other IDs
- 2008 000073 37, 08/H0606/31, 2008
- Acronym
- Free4Flow
- Status last verified
- Aug 2011
- First submitted
- 15 Aug 2011
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22929242
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study
- ClinicalTrials.gov ID
- NCT01418118
- Acronym / sponsor ID
- Free4Flow / 2008-000073-37 5579
- Conditions
- Oral Cancer, Head and Neck Cancer, Free Flap, Hypotension
- Keywords
- noradrenaline, norepinephrine, epinephrine, adrenaline, dobutamine, dopexamine, inotrope, pressor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressors | Experimental | Drug: Epinephrine, Drug: Norepinephrine, Drug: Dobutamine, Drug: DopexamineEpinephrine, Norepinephrine, Dobutamine, Dopexamine |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit.
Key exclusion criteria (4 listed)
- Pregnancy
- Weight >100kg
- Contraindications to pressor infusions
- Overnight ventilation not indicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg | Drug | Pressors |
| NorepinephrineMaximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg | Drug | Pressors |
| DobutamineMaximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg | Drug | Pressors |
| DopexamineMaximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg | Drug | Pressors |
Primary outcome
Absolute change in transfer function (flap vascular resistance) after pressor infusion.
Time frame: Post infusion (at 4 hours)
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
- Derived from this study: PubMed 22929242Eley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen R Watt-Smith, FDSRCS, MD principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epinephrine, Norepinephrine and Dobutamine in people with Oral Cancer and Head and Neck Cancer, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in transfer function (flap vascular resistance) after pressor infusion. (time frame: Post infusion (at 4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01418118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011.