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Completed

NCT Number: NCT01129037

Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital, UHN

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goal directed fluid management based on continuous monitoring of stroke volume

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
May 24, 2010
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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