| Registry | NCT02864355 |
|---|
| Status | Terminated - Minimally invasive surgical methods have ceased enrollment |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; randomized, parallel, masking: none, treatment |
|---|
| Enrollment | 53 (Actual) |
|---|
| Sponsor | Medical University of South Carolina (Other) |
|---|
| Conditions | Esophageal Cancer |
|---|
| Interventions | Goal Directed Therapy (Device) |
|---|
| Dates | start 2016-06-01, primary completion 2020-03-01, completion 2020-03-01, first posted 2016-08-12, last updated 2021-03-02 |
|---|
| Locations | 1 site in United States |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Esophageal Cancer All trials of Goal Directed Therapy
-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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Goal Directed Therapy | Active comparator | Device: 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. |
| Usual Care | No intervention | | Standard of care will be used to manage blood pressures. |
- 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.
+Outcome measures
Primary outcomes
- Number of Participants With Cardiopulmonary Complications [7 days]: Any documented cardiopulmonary complications present upon chart review.
Secondary outcomes
- 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]
+Eligibility
Sex: All, ages: 18 Years to any
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
+Posted results
Participant flow
| Milestone | Goal Directed Therapy | Usual Care |
|---|
| Started | 25 | 28 |
| Completed | 23 | 25 |
| Not completed | 2 | 3 |
Outcome results
- Number of Participants With Cardiopulmonary Complications (Primary), Count of participants, Participants: Goal Directed Therapy 8; Usual Care 11
- Anastomotic Leak Diagnosed Via Radiograph (Secondary), Count of participants, Participants: Goal Directed Therapy 1; Usual Care 1
- Number of Participants With Renal Injury (Secondary), Count of participants, Participants: Goal Directed Therapy 3; Usual Care 3
- Death (Secondary), Count of participants, Participants: Goal Directed Therapy 2; Usual Care 1
- Length of Intensive Care Unit Stay (Secondary), Median, hours: Goal Directed Therapy 30.3 (24.8 to 69.8); Usual Care 42.3 (27.4 to 46.9)
- Hospital Length of Stay (Secondary), Median, days: Goal Directed Therapy 10.8 (9.3 to 19.9); Usual Care 9.0 (8.0 to 12.1)
Adverse events
Time frame: 30 days
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Goal Directed Therapy | 2/23 (8.7%) | 0/23 (0.0%) | 0/23 (0.0%) |
| Usual Care | 1/25 (4.0%) | 0/25 (0.0%) | 0/25 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Medical University of South Carolina | Charleston, South Carolina | United States | |
+Study documents
+Investigators