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

Stopped early · Not applicable

Conditions studied: Esophageal Cancer

In brief

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.

Key facts

Study ID

NCT02864355

Run by

Medical University of South Carolina

People needed

53

Starts

2016-06-01

Expected to finish

2020-03-01

Last updated by the study team

2021-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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