Free Flap Post MastectomyNCT00869297
Goal Directed Fluid Therapy in Free Flap Patients
A study testing Goal Directed Fluid Administration in people with Free Flap Post Mastectomy, run by University of Manitoba at 1 site in Canada.
Trial summary
Fluid management of surgical patients has changed dramatically in recent years. Recent studies have shown that so called 'restrictive' fluid strategies can improve outcomes such as length of stay and time to fitness for discharge. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Free Flap Post Mastectomy
- What is being tested?
- Goal Directed Fluid Administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Oct 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-80 undergoing primary microvascular free flap reconstruction after mastectomy.
Who cannot join
- Weight >120kg Known or Suspected Aortic Insufficiency Renal Dysfunction (serum creatinine >150 μmol/l)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal Directed Fluid Therapy for Microvascular Free Flap Reconstruction Following Mastectomy: A Pilot Study
Fluid management of surgical patients has changed dramatically in recent years. Recent studies have shown that so called 'restrictive' fluid strategies can improve outcomes such as length of stay and time to fitness for discharge. Furthermore, new monitoring technologies have been developed that allow the clinician to better monitor the effects of intravenous fluid therapy.
The fluid management of free flap reconstruction surgery is controversial. As vasoactive agent use during the anesthetic is not the preferred intervention for the treatment of hypotension, fluid therapy is often administered to correct hemodynamic instability. A liberal fluid strategy may predispose the flap to edema, venous congestion and ultimately flap failure. A restrictive fluid strategy however has (at this institution) anecdotally been reported to lead to a higher incidence of deep venous thrombosis (DVT) and pulmonary embolus (PE). Thus, there is clinical equipoise as to the optimal fluid management for these patients.
Read more
Non-invasive cardiac output (CO) monitoring based on the arterial pulse contour is a nascent technological advance that has been widely validated in the operating theatre. The calculation of CO is based on the assumption that stroke volume is proportional to the integral of the area under the arterial pressure versus time curve. With these monitors, the variation in stroke volume during mechanical ventilation is also calculated and this can be utilized as an estimate of the patient's volume status. A stroke volume variation (SVV) of less than 15% has been shown to be indicative that a patient is no longer volume responsive.
In our study, we plan to recruit patients undergoing microvascular free flap reconstruction. Patients will be randomized to either standard care, or goal directed fluid therapy.
All patients will receive a pre-operative 5 ml kg-1 bolus of normal saline. Subsequently, all patients will then receive lactated ringers at a rate of 5 ml kg-1 hr-1. Patients in the intervention group will have their CO and SVV monitored by a Flo-Trac pulse contour monitor (Edwards Life Sciences, Irvine, CA). Patients in the intervention group will receive 6% tetrastarch boluses (Voluven, Fresenius Kabi, Hamburg, Germany) if their SVV exceeds 15%. Patients in the control arm will receive fluid at a rate and type at the discretion of the attending anesthesiologist to maintain hemodynamic stability and a urine output of 0.5 ml kg-1 hr-1.
Intra-operative variables studied will include total fluid administered (colloid and crystalloid), urine output, SVV and CO (both at the start and end of surgery). Postoperative variables examined will be urine output, daily fluid balance (days 0-3), incidence of DVT, PE, pulmonary edema, rate of re-operation, daily serum creatinine, chloride and bicarbonate concentration, and incidence of flap failure.
Measurements of flap oxygenation and water content will be made with near infrared spectroscopy at baseline, and during the immediate post-operative period (days 1-7).
We hypothesize that the goal directed group would have more intra-operative colloid given with a reduced incidence of adverse outcomes.
- Conditions
- Free Flap Post Mastectomy
- Being tested
- Goal Directed Fluid Administration, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Directed Fluid AdministrationOther
Intravenous Fluid will be given if SVV exceeds 13%
ControlOther
Fluids titrated at discretion of anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: Control |
| Intervention | Experimental | These patients receive fluid boluses based on measurements from the FloTrac Receives: Other: Goal Directed Fluid Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap Oxygenation and Tissue Water
Measured: 3 days
Secondary outcomes (1)
Total IV fluid administered during the first 24 hours
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Flap Post MastectomyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869297
- Sponsor's protocol ID
- B2008:135
- Status last verified
- Apr 2011
- First submitted
- 24 Mar 2009
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Fluid Therapy for Microvascular Free Flap Reconstruction Following Mastectomy: A Pilot Study
- ClinicalTrials.gov ID
- NCT00869297
- Acronym / sponsor ID
- B2008:135
- Conditions
- Free Flap Post Mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Mar 2009 (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.
Fluid management of surgical patients has changed dramatically in recent years. Recent studies have shown that so called 'restrictive' fluid strategies can improve outcomes such as length of stay and time to fitness for discharge. Furthermore, new monitoring technologies have been developed that allow the clinician to better monitor the effects of intravenous fluid therapy.
The fluid management of free flap reconstruction surgery is controversial. As vasoactive agent use during the anesthetic is not the preferred intervention for the treatment of hypotension, fluid therapy is often administered to correct hemodynamic instability. A liberal fluid strategy may predispose the flap to edema, venous congestion and ultimately flap failure. A restrictive fluid strategy however has (at this institution) anecdotally been reported to lead to a higher incidence of deep venous thrombosis (DVT) and pulmonary embolus (PE). Thus, there is clinical equipoise as to the optimal fluid management for these patients.
Non-invasive cardiac output (CO) monitoring based on the arterial pulse contour is a nascent technological advance that has been widely validated in the operating theatre. The calculation of CO is based on the assumption that stroke volume is proportional to the integral of the area under the arterial pressure versus time curve. With these monitors, the variation in stroke volume during mechanical ventilation is also calculated and this can be utilized as an estimate of the patient's volume status. A stroke volume variation (SVV) of less than 15% has been shown to be indicative that a patient is no longer volume responsive.
In our study, we plan to recruit patients undergoing microvascular free flap reconstruction. Patients will be randomized to either standard care, or goal directed fluid therapy.
All patients will receive a pre-operative 5 ml kg-1 bolus of normal saline. Subsequently, all patients will then receive lactated ringers at a rate of 5 ml kg-1 hr-1. Patients in the intervention group will have their CO and SVV monitored by a Flo-Trac pulse contour monitor (Edwards Life Sciences, Irvine, CA). Patients in the intervention group will receive 6% tetrastarch boluses (Voluven, Fresenius Kabi, Hamburg, Germany) if their SVV exceeds 15%. Patients in the control arm will receive fluid at a rate and type at the discretion of the attending anesthesiologist to maintain hemodynamic stability and a urine output of 0.5 ml kg-1 hr-1.
Intra-operative variables studied will include total fluid administered (colloid and crystalloid), urine output, SVV and CO (both at the start and end of surgery). Postoperative variables examined will be urine output, daily fluid balance (days 0-3), incidence of DVT, PE, pulmonary edema, rate of re-operation, daily serum creatinine, chloride and bicarbonate concentration, and incidence of flap failure.
Measurements of flap oxygenation and water content will be made with near infrared spectroscopy at baseline, and during the immediate post-operative period (days 1-7).
We hypothesize that the goal directed group would have more intra-operative colloid given with a reduced incidence of adverse outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control |
| Intervention | Experimental | Other: Goal Directed Fluid AdministrationThese patients receive fluid boluses based on measurements from the FloTrac |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients aged 18-80 undergoing primary microvascular free flap reconstruction after mastectomy.
Key exclusion criteria (1 listed)
- Weight >120kg Known or Suspected Aortic Insufficiency Renal Dysfunction (serum creatinine >150 μmol/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 AdministrationIntravenous Fluid will be given if SVV exceeds 13% | Other | Intervention |
| ControlFluids titrated at discretion of anesthesiologist. | Other | Control |
Primary outcome
Flap Oxygenation and Tissue Water
Time frame: 3 days
1 secondary outcome
Total IV fluid administered during the first 24 hours
Time frame: 24 hrs
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 19 Apr 2011.
Related trials for Free Flap Post Mastectomy
Recruiting
Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
Breast Cancer Surgery, Reconstruction Breast Surgery
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 study testing Goal Directed Fluid Administration in people with Free Flap Post Mastectomy, run by University of Manitoba 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 1 inclusion and 1 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 19 Apr 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 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?
Flap Oxygenation and Tissue Water (time frame: 3 days). 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 19 Apr 2011.