Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Other: Goal directed fluid management based on continuous monitoring of stroke volume

• Registration Number: NCT01129037
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-24
• Study Start: 2010-07
• Primary Completion: 2012-05
• Study Completion: 2013-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Age 18-80 years
• Signed informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal directed fluid management	Goal directed fluid management based on continuous monitoring of stroke volume	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of major complication and LOS	Post operative day 0 to hospital discharge	Cardiovascular, respiratory, neurologic, thromboembolic, renal,liver, GI, sepsis,and surgical complications willl be recorded

Trial Locations

Locations (1)

Toronto General Hospital, UHN; 🇨🇦 Toronto, Ontario, Canada