Head and Neck CancerNCT01129037
Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery
A study testing Goal directed fluid management based on continuous monitoring of stroke volume in people with Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR) results to a high cancer cure rate and a good functional recovery. However, this long complex procedure is accompanied with considerable complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Goal directed fluid management based on continuous monitoring of stroke volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Feb 2013
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Signed informed consent
Who cannot join
- History CHF
- Severe valvular heart defects, intra cardiac shunts
- Irregular heart rhythm
- Allergy to hydroxyethyl starch solutions
- Coagulation abnormalities (INR>1.5, aPTT>40s, platelet count<100x10 9/L
- History of severe bleeding disorders
Show all 9Show fewer
- Renal insufficiency with creatinine >200Umol/L
- Pregnant of nursing women
- History of skin disorders that are accompanied by chronic puritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial
Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR) results to a high cancer cure rate and a good functional recovery. However, this long complex procedure is accompanied with considerable complications. Excessive fluid administration during this type of surgery has been connected with poor results. There is growing evidence that goal-directed fluid management (GDFM) might improve the results in high-risk patients.
Hypothesis: Goal directed fluid management will reduce intraoperative fluid volume administered to patients undergoing head and neck reconstructive surgery.
- Conditions
- Head and Neck Cancer
- Being tested
- Goal directed fluid management based on continuous monitoring of stroke volume
- Keywords
- Oncology
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal directed fluid management based on continuous monitoring of stroke volumeOther
Baseline SV measurement, repeated volume loading (VL) with aliquots of 250 ml HES until SV increased < 10% in response to receding VL: SV is optimized, no further VL required.
| Study group | Role | What they receive |
|---|---|---|
| Goal directed fluid management | Other | Not described Receives: Other: Goal directed fluid management based on continuous monitoring of stroke volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology
Measured: Initiation of surgery to end of surgery on average 8-10 hours
Secondary outcomes (1)
Incidence of major complication and LOS
Cardiovascular, respiratory, neurologic, thromboembolic, renal,liver, GI, sepsis,and surgical complications willl be recorded
Measured: Post operative day 0 to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionFeb 2013
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 University Health Network, TorontoThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonid Minkovich, MD, Principal investigator, Toronto General Hospital, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129037
- Sponsor's protocol ID
- UHN REB 09-0084BE
- Status last verified
- Apr 2015
- First submitted
- 17 May 2010
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01129037
- Acronym / sponsor ID
- UHN REB 09-0084BE
- Conditions
- Head and Neck Cancer
- Keywords
- Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 May 2010 (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.
Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR) results to a high cancer cure rate and a good functional recovery. However, this long complex procedure is accompanied with considerable complications. Excessive fluid administration during this type of surgery has been connected with poor results. There is growing evidence that goal-directed fluid management (GDFM) might improve the results in high-risk patients.
Hypothesis: Goal directed fluid management will reduce intraoperative fluid volume administered to patients undergoing head and neck reconstructive surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Goal directed fluid management | Other | Other: Goal directed fluid management based on continuous monitoring of stroke volume |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80 years
- Signed informed consent
Key exclusion criteria (9 listed)
- History CHF
- Severe valvular heart defects, intra cardiac shunts
- Irregular heart rhythm
- Allergy to hydroxyethyl starch solutions
- Coagulation abnormalities (INR>1.5, aPTT>40s, platelet count<100x10 9/L
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 |
|---|---|---|
| Goal directed fluid management based on continuous monitoring of stroke volumeBaseline SV measurement, repeated volume loading (VL) with aliquots of 250 ml HES until SV increased < 10% in response to receding VL: SV is optimized, no further VL required. | Other | Goal directed fluid management |
Primary outcome
The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology
Time frame: Initiation of surgery to end of surgery on average 8-10 hours
1 secondary outcome
Incidence of major complication and LOS
Time frame: Post operative day 0 to hospital discharge
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 21 Apr 2015.
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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.
Leonid Minkovich, MD principal investigator
Toronto General Hospital, UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal directed fluid management based on continuous monitoring of stroke volume in people with Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 2 inclusion and 9 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 21 Apr 2015. 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 Canada. 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.
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?
The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology (time frame: Initiation of surgery to end of surgery on average 8-10 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 21 Apr 2015.