Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

NCT ID: NCT01129037

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-02-28

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Goal directed fluid management

Group Type: OTHER

Goal directed fluid management based on continuous monitoring of stroke volume

Intervention Type: OTHER

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.

Interventions

Goal directed fluid management based on continuous monitoring of stroke volume

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonid Minkovich, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital, UHN

Locations

Toronto General Hospital, UHN

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 09-0084BE

Identifier Type: -

Identifier Source: org_study_id