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Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

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ClinicalTrials.gov Identifier: NCT01129037
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2010
Primary Completion Date : May 2012
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01129037     History of Changes
Other Study ID Numbers: UHN REB 09-0084BE
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by University Health Network, Toronto:
Oncology

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