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Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial


N/A
18 Years
80 Years
Not Enrolling
Both
Head and Neck Cancer

Thank you

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

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