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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

May 17, 2010
February 21, 2013
July 2010
May 2012   (final data collection date for primary outcome measure)
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 ]
The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology [ Time Frame: Initiation of surgery to end of surgery ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01129037 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery
Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Head and Neck Cancer
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.
Goal directed fluid management
Intervention: Other: Goal directed fluid management based on continuous monitoring of stroke volume
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
February 2013
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01129037
UHN REB 09-0084BE
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Leonid Minkovich, MD Toronto General Hospital, UHN
University Health Network, Toronto
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP