Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

University Health Network, Toronto

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Other: Goal directed fluid management based on continuous monitoring of stroke volume

Study type: Interventional

Funder types: Other

Identifiers

NCT01129037

UHN REB 09-0084BE

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 1 patient group

Goal directed fluid management

Other group

Treatment:

Other: Goal directed fluid management based on continuous monitoring of stroke volume