Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129037
• Other study ID #: UHN REB 09-0084BE
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: April 17, 2015
• Start date: July 2010
• Est. completion date: February 2013

Study information

• Verified date: April 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital, UHN	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Incidence of major complication and LOS	Cardiovascular, respiratory, neurologic, thromboembolic, renal,liver, GI, sepsis,and surgical complications willl be recorded	Post operative day 0 to hospital discharge	Yes