Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery
Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial
1 other identifier
interventional
78
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable head-and-neck-cancer
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedApril 21, 2015
April 1, 2015
1.8 years
May 17, 2010
April 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology
Initiation of surgery to end of surgery on average 8-10 hours
Secondary Outcomes (1)
Incidence of major complication and LOS
Post operative day 0 to hospital discharge
Study Arms (1)
Goal directed fluid management
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- Age 18-80 years
- Signed informed consent
You may not qualify if:
- 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
- Renal insufficiency with creatinine \>200Umol/L
- Pregnant of nursing women
- History of skin disorders that are accompanied by chronic puritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital, UHN
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonid Minkovich, MD
Toronto General Hospital, UHN
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 24, 2010
Study Start
July 1, 2010
Primary Completion
May 1, 2012
Study Completion
February 1, 2013
Last Updated
April 21, 2015
Record last verified: 2015-04