Esophageal Cancer
Conditions
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.
Interventions
DEVICEGoal 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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cardiopulmonary Complications | 7 days | Any documented cardiopulmonary complications present upon chart review. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment was stopped early due to to insufficient enrollment accruals
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 23 |
| Usual Care Standard of care will be used to manage blood pressures. | 25 |
| Total | 48 |
Baseline characteristics
| Characteristic | Usual Care | Total | Goal Directed Therapy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 26 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 22 Participants | 10 Participants |
| Age, Continuous | 62.8 years STANDARD_DEVIATION 15.2 | 63.9 years STANDARD_DEVIATION 12.2 | 65.1 years STANDARD_DEVIATION 8.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 42 Participants | 19 Participants |
| Region of Enrollment United States | 25 Participants | 48 Participants | 23 Participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Male | 17 Participants | 33 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 23 | 1 / 25 |
| other Total, other adverse events | 0 / 23 | 0 / 25 |
| serious Total, serious adverse events | 0 / 23 | 0 / 25 |
Outcome results
Primary
Number of Participants With Cardiopulmonary Complications
Any documented cardiopulmonary complications present upon chart review.
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Goal Directed Therapy | Number of Participants With Cardiopulmonary Complications | 8 Participants |
| Usual Care | Number of Participants With Cardiopulmonary Complications | 11 Participants |
Secondary
Anastomotic Leak Diagnosed Via Radiograph
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Goal Directed Therapy | Anastomotic Leak Diagnosed Via Radiograph | 1 Participants |
| Usual Care | Anastomotic Leak Diagnosed Via Radiograph | 1 Participants |
Secondary
Death
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Goal Directed Therapy | Death | 2 Participants |
| Usual Care | Death | 1 Participants |
Secondary
Hospital Length of Stay
Time frame: 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Goal Directed Therapy | Hospital Length of Stay | 10.8 days |
| Usual Care | Hospital Length of Stay | 9.0 days |
Secondary
Length of Intensive Care Unit Stay
Time frame: 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Goal Directed Therapy | Length of Intensive Care Unit Stay | 30.3 hours |
| Usual Care | Length of Intensive Care Unit Stay | 42.3 hours |
Secondary
Number of Participants With Renal Injury
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Goal Directed Therapy | Number of Participants With Renal Injury | 3 Participants |
| Usual Care | Number of Participants With Renal Injury | 3 Participants |