Trial Outcomes & Findings for Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients (NCT NCT02864355)
NCT ID: NCT02864355
Last Updated: 2021-03-02
Results Overview
Any documented cardiopulmonary complications present upon chart review.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
7 days
Results posted on
2021-03-02
Participant Flow
Recruitment was stopped early due to to insufficient enrollment accruals
Participant milestones
| Measure |
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.
|
Usual Care
Standard of care will be used to manage blood pressures.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
28
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients
Baseline characteristics by cohort
| Measure |
Goal Directed Therapy
n=23 Participants
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.
|
Usual Care
n=25 Participants
Standard of care will be used to manage blood pressures.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
62.8 years
STANDARD_DEVIATION 15.2 • n=107 Participants
|
63.9 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 daysAny documented cardiopulmonary complications present upon chart review.
Outcome measures
| Measure |
Goal Directed Therapy
n=23 Participants
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.
|
Usual Care
n=25 Participants
Standard of care will be used to manage blood pressures.
|
|---|---|---|
|
Number of Participants With Cardiopulmonary Complications
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Goal Directed Therapy
n=23 Participants
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.
|
Usual Care
n=25 Participants
Standard of care will be used to manage blood pressures.
|
|---|---|---|
|
Anastomotic Leak Diagnosed Via Radiograph
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Goal Directed Therapy
n=23 Participants
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.
|
Usual Care
n=25 Participants
Standard of care will be used to manage blood pressures.
|
|---|---|---|
|
Number of Participants With Renal Injury
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Goal Directed Therapy
n=23 Participants
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.
|
Usual Care
n=25 Participants
Standard of care will be used to manage blood pressures.
|
|---|---|---|
|
Death
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Goal Directed Therapy
n=23 Participants
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.
|
Usual Care
n=25 Participants
Standard of care will be used to manage blood pressures.
|
|---|---|---|
|
Length of Intensive Care Unit Stay
|
30.3 hours
Interval 24.8 to 69.8
|
42.3 hours
Interval 27.4 to 46.9
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Goal Directed Therapy
n=23 Participants
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.
|
Usual Care
n=25 Participants
Standard of care will be used to manage blood pressures.
|
|---|---|---|
|
Hospital Length of Stay
|
10.8 days
Interval 9.3 to 19.9
|
9.0 days
Interval 8.0 to 12.1
|
Adverse Events
Goal Directed Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
George Guldan, MD
The Medical University of South Carolina
Phone: 843-876-5744
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place