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

Medical University of South Carolina1 site in 1 country53 target enrollmentJune 2016

ConditionsEsophageal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Esophageal Cancer
Sponsor: Medical University of South Carolina
Enrollment: 53
Locations: 1
Primary Endpoint: Number of Participants With Cardiopulmonary Complications
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

March 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medical University of South Carolina

Responsible Party

Sponsor

Eligibility Criteria

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