Head and Neck CancerPhase 4NCT02241083
The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements
A Phase 4 study testing Dopamine, Norepinephrine and no medication in people with Head and Neck Cancer, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Vasopressors may be needed after head and neck microvascular reconstructions to maintain sufficient mean arterial pressure. This is crucial for the flap survival. The study hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue oxygen level and microdialysate metabolites. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Dopamine, Norepinephrine and no medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2006to May 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- head and neck cancer patients having tumor ablation surgery and reconstruction with microvascular radial forearm flap
Who cannot join
- Patients having contraindications for the operation.
- Patient refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Vasopressors may be needed after head and neck microvascular reconstructions to maintain sufficient mean arterial pressure. This is crucial for the flap survival. The study hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue oxygen level and microdialysate metabolites.
- Conditions
- Head and Neck Cancer
- Being tested
- Dopamine, Norepinephrine, no medication
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopamineDrug
NorepinephrineDrug
no medicationOther
| Study group | Role | What they receive |
|---|---|---|
| dopamine group | Active comparator | vasopressor dosage individually titred according to the mean arterial pressure Receives: Drug: Dopamine |
| norepinephrine group | Active comparator | vasopressor dosage individually titred according to the mean arterial pressure Receives: Drug: Norepinephrine |
| control group | Active comparator | no medication Receives: Other: no medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJun 2006
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minna Kääriäinen, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241083
- Sponsor's protocol ID
- R05114
- Status last verified
- Sep 2014
- First submitted
- 12 Sep 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements
- ClinicalTrials.gov ID
- NCT02241083
- Acronym / sponsor ID
- R05114
- Conditions
- Head and Neck Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- May 2014 (actual)
- First posted
- 16 Sep 2014 (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.
Vasopressors may be needed after head and neck microvascular reconstructions to maintain sufficient mean arterial pressure. This is crucial for the flap survival. The study hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue oxygen level and microdialysate metabolites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dopamine group | Active comparator | Drug: Dopaminevasopressor dosage individually titred according to the mean arterial pressure |
| norepinephrine group | Active comparator | Drug: Norepinephrinevasopressor dosage individually titred according to the mean arterial pressure |
| control group | Active comparator | Other: no medicationno medication |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- head and neck cancer patients having tumor ablation surgery and reconstruction with microvascular radial forearm flap
Key exclusion criteria (2 listed)
- Patients having contraindications for the operation.
- Patient refusal to participate in the study
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 |
|---|---|---|
| Dopamine | Drug | dopamine group |
| Norepinephrine | Drug | norepinephrine group |
| no medication | Other | control group |
Primary outcome
Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites
Time frame: 72 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 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dopamine, Norepinephrine and no medication in people with Head and Neck Cancer, run by Tampere University Hospital at 1 site in Finland.
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 2 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 Sep 2014. 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 Finland. 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?
Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2014.