Trial Information
Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial
Inclusion Criteria:
- Age 18-80 years
- Signed informed consent
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology
Outcome Time Frame:
Initiation of surgery to end of surgery on average 8-10 hours
Safety Issue:
Yes
Principal Investigator
Leonid Minkovich, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Toronto General Hospital, UHN
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 09-0084BE
NCT ID:
NCT01129037
Start Date:
July 2010
Completion Date:
February 2013
Related Keywords:
- Head and Neck Cancer
- Oncology
- Head and Neck Neoplasms