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

Medical University of South Carolina (MUSC)

Status: Terminated

Conditions: Esophageal Cancer

Treatments: Device: Goal Directed Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02864355

Pro00045623

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Goal Directed Therapy

Active Comparator group

Description:

In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures.

Treatment:

Device: Goal Directed Therapy

Usual Care

No Intervention group

Description:

Standard of care will be used to manage blood pressures.