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

Not Applicable

Terminated

• Conditions: Esophageal Cancer
• Interventions: Device: Goal Directed Therapy

• Registration Number: NCT02864355
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-12
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Results First Submitted: 2020-12-17
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Results First Posted: 2021-03-02
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal Directed Therapy	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Cardiopulmonary Complications	7 days	Any documented cardiopulmonary complications present upon chart review.

Secondary Outcome Measures

Name	Time	Method
Hospital Length of Stay	30 days
Anastomotic Leak Diagnosed Via Radiograph	7 days
Number of Participants With Renal Injury	7 days
Death	30 days
Length of Intensive Care Unit Stay	30 days

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States