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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02864355
• Other study ID #: Pro00045623
• Status: Terminated
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 2020

Study information

• Verified date: February 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Cardiopulmonary Complications	Any documented cardiopulmonary complications present upon chart review.	7 days
Secondary	Anastomotic Leak Diagnosed Via Radiograph		7 days
Secondary	Number of Participants With Renal Injury		7 days
Secondary	Death		30 days
Secondary	Length of Intensive Care Unit Stay		30 days
Secondary	Hospital Length of Stay		30 days