Goal Directed Fluid Therapy in Free Flap Patients

April 18, 2011 updated by: University of Manitoba

Goal Directed Fluid Therapy for Microvascular Free Flap Reconstruction Following Mastectomy: A Pilot Study

Fluid management of surgical patients has changed dramatically in recent years. Recent studies have shown that so called 'restrictive' fluid strategies can improve outcomes such as length of stay and time to fitness for discharge. Furthermore, new monitoring technologies have been developed that allow the clinician to better monitor the effects of intravenous fluid therapy.

The fluid management of free flap reconstruction surgery is controversial. As vasoactive agent use during the anesthetic is not the preferred intervention for the treatment of hypotension, fluid therapy is often administered to correct hemodynamic instability. A liberal fluid strategy may predispose the flap to edema, venous congestion and ultimately flap failure. A restrictive fluid strategy however has (at this institution) anecdotally been reported to lead to a higher incidence of deep venous thrombosis (DVT) and pulmonary embolus (PE). Thus, there is clinical equipoise as to the optimal fluid management for these patients.

Non-invasive cardiac output (CO) monitoring based on the arterial pulse contour is a nascent technological advance that has been widely validated in the operating theatre. The calculation of CO is based on the assumption that stroke volume is proportional to the integral of the area under the arterial pressure versus time curve. With these monitors, the variation in stroke volume during mechanical ventilation is also calculated and this can be utilized as an estimate of the patient's volume status. A stroke volume variation (SVV) of less than 15% has been shown to be indicative that a patient is no longer volume responsive.

In our study, we plan to recruit patients undergoing microvascular free flap reconstruction. Patients will be randomized to either standard care, or goal directed fluid therapy.

All patients will receive a pre-operative 5 ml kg-1 bolus of normal saline. Subsequently, all patients will then receive lactated ringers at a rate of 5 ml kg-1 hr-1. Patients in the intervention group will have their CO and SVV monitored by a Flo-Trac pulse contour monitor (Edwards Life Sciences, Irvine, CA). Patients in the intervention group will receive 6% tetrastarch boluses (Voluven, Fresenius Kabi, Hamburg, Germany) if their SVV exceeds 15%. Patients in the control arm will receive fluid at a rate and type at the discretion of the attending anesthesiologist to maintain hemodynamic stability and a urine output of 0.5 ml kg-1 hr-1.

Intra-operative variables studied will include total fluid administered (colloid and crystalloid), urine output, SVV and CO (both at the start and end of surgery). Postoperative variables examined will be urine output, daily fluid balance (days 0-3), incidence of DVT, PE, pulmonary edema, rate of re-operation, daily serum creatinine, chloride and bicarbonate concentration, and incidence of flap failure.

Measurements of flap oxygenation and water content will be made with near infrared spectroscopy at baseline, and during the immediate post-operative period (days 1-7).

We hypothesize that the goal directed group would have more intra-operative colloid given with a reduced incidence of adverse outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T4P6
        • University of Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients aged 18-80 undergoing primary microvascular free flap reconstruction after mastectomy.

Exclusion Criteria:

  • Weight >120kg Known or Suspected Aortic Insufficiency Renal Dysfunction (serum creatinine >150 μmol/l)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Control
Other: Control
Fluids titrated at discretion of anesthesiologist.
EXPERIMENTAL: Intervention
These patients receive fluid boluses based on measurements from the FloTrac
Other: Goal Directed Fluid Administration
Intravenous Fluid will be given if SVV exceeds 13%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Flap Oxygenation and Tissue Water
Time Frame: 3 days
3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Total IV fluid administered during the first 24 hours
Time Frame: 24 hrs
24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2008:135

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