Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients

February 10, 2021 updated by: Medical University of South Carolina
The objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital stay.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • 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

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29461
        • Medical University of South Carolina

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years of age or older
  • Patients undergoing primary resection of esophageal cancer and resultant esophagectomy.

Exclusion Criteria:

  • Patients < 55kg or > 140 kg, based on literature regarding accuracy of FloTrac.
  • Patients with sustained preoperative dysrhythmias, based on literature regarding accuracy of FloTrac (atrial flutter and/or atrial fibrillation).
  • Patients with diagnosed NYHA class III-IV failure or documented EF < 30%
  • Patients who are unable/unwilling to consent for study procedures

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Goal Directed Therapy
In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures.
Device: Goal Directed Therapy
Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures.
No Intervention: Usual Care
Standard of care will be used to manage blood pressures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Cardiopulmonary Complications
Time Frame: 7 days
Any documented cardiopulmonary complications present upon chart review.
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital Length of Stay
Time Frame: 30 days
30 days
Death
Time Frame: 30 days
30 days
Anastomotic Leak Diagnosed Via Radiograph
Time Frame: 7 days
7 days
Number of Participants With Renal Injury
Time Frame: 7 days
7 days
Length of Intensive Care Unit Stay
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: George Guldan, MD, Medical University of South Carolina

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

June 1, 2016

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00045623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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