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
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||Phase|
|Head and Neck Cancer||Other: Goal directed fluid management based on continuous monitoring of stroke volume||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||February 2013|
|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.
- 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 ]
- 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
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
|Toronto General Hospital, UHN|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Leonid Minkovich, MD||Toronto General Hospital, UHN|