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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01129037

Enrollment

Registered

2010-05-24

Start date

2010-07-31

Completion date

2013-02-28

Last updated

2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

Oncology

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.

Interventions

OTHERGoal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology	Initiation of surgery to end of surgery on average 8-10 hours

Secondary

Measure	Time frame	Description
Incidence of major complication and LOS	Post operative day 0 to hospital discharge	Cardiovascular, respiratory, neurologic, thromboembolic, renal,liver, GI, sepsis,and surgical complications willl be recorded

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026