Text Size

Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01129037
First received: May 17, 2010
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Head and Neck Cancer
 Other: Goal directed fluid management based on continuous monitoring of stroke volume

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology [ Time Frame: Initiation of surgery to end of surgery on average 8-10 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of major complication and LOS [ Time Frame: Post operative day 0 to hospital discharge ] [ Designated as safety issue: Yes ]
    Cardiovascular, respiratory, neurologic, thromboembolic, renal,liver, GI, sepsis,and surgical complications willl be recorded


Enrollment: 78
Study Start Date: July 2010
Study Completion Date: February 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Goal directed fluid management 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129037

Locations
Canada, Ontario
Toronto General Hospital, UHN
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Leonid Minkovich, MD Toronto General Hospital, UHN
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01129037     History of Changes
Other Study ID Numbers: UHN REB 09-0084BE
Study First Received: May 17, 2010
Last Updated: February 21, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Oncology

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013