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

NCT02864355 | Terminated Results DMC

• 1 other identifier: Pro00045623
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Cardiopulmonary Complications

  Any documented cardiopulmonary complications present upon chart review.

  7 days

Secondary Outcomes (5)

• 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

• Hospital Length of Stay

  30 days

Study Arms (2)

Goal Directed Therapy

ACTIVE COMPARATOR

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

Device: Goal Directed Therapy

Usual Care

NO INTERVENTION

Standard of care will be used to manage blood pressures.

Interventions

Goal Directed Therapy DEVICE

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.

Goal Directed Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29461, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Early Goal-Directed Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Critical Care; Patient Care; Therapeutics

Results Point of Contact

• Title: George Guldan, MD
• Organization: The Medical University of South Carolina

guldan@musc.edu

843-876-5744

Study Officials

• George Guldan, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 12, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 2, 2021
• Results First Posted: March 2, 2021

Record last verified: 2021-02

Locations

US (1)