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Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Goal directed fluid management based on continuous monitoring of stroke volume
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer focused on measuring Oncology

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Toronto General Hospital, UHN

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Goal directed fluid management

Arm Description

Outcomes

Primary Outcome Measures

The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology

Secondary Outcome Measures

Incidence of major complication and LOS
Cardiovascular, respiratory, neurologic, thromboembolic, renal,liver, GI, sepsis,and surgical complications willl be recorded

Full Information

First Posted
May 17, 2010
Last Updated
April 17, 2015
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01129037
Brief Title
Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Oncology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal directed fluid management
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Goal directed fluid management based on continuous monitoring of stroke volume
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Incidence of major complication and LOS
Description
Cardiovascular, respiratory, neurologic, thromboembolic, renal,liver, GI, sepsis,and surgical complications willl be recorded
Time Frame
Post operative day 0 to hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonid Minkovich, MD
Organizational Affiliation
Toronto General Hospital, UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital, UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

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Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery

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