Trial Outcomes & Findings for Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT) (NCT NCT01128413)
NCT ID: NCT01128413
Last Updated: 2016-04-01
Results Overview
The median lactate clearance from time zero to within 6 hours of the ED stay.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
The median lactate clearance within 6 hours of the ED stay.
Results posted on
2016-04-01
Participant Flow
Patients screened and study performed in the ED from July 2010 to November 2013.
Participant milestones
| Measure |
Fluid Optimization (FO)
Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a \>/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI \<15% will receive a saline lock.
|
Routine Care (RC)
Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Fluid Optimization (FO)
Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a \>/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI \<15% will receive a saline lock.
|
Routine Care (RC)
Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
NICOM Monitor Problems
|
2
|
1
|
|
Overall Study
Pt made DNR
|
1
|
0
|
Baseline Characteristics
Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT)
Baseline characteristics by cohort
| Measure |
Fluid Optimization (FO)
n=11 Participants
Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a \>/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI \<15% will receive a saline lock.
|
Routine Care (RC)
n=11 Participants
Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
n=5 Participants
|
59 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The median lactate clearance within 6 hours of the ED stay.Population: Only 9 total patients (5 Fluid Optimization; 4 Routine Care) stayed in the Emergency Department for a full 6 hours to allow calculation of a 6 hour lactate clearance. The rest of the patients left were dispositioned out of the ED before the 6 hour mark and therefore unable to calculate a 6 hour lactate clearance.
The median lactate clearance from time zero to within 6 hours of the ED stay.
Outcome measures
| Measure |
Fluid Optimization (FO)
n=5 Participants
Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a \>/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI \<15% will receive a saline lock.
|
Routine Care (RC)
n=4 Participants
Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
|
|---|---|---|
|
Lactate Clearance
|
54 percent lactate clearance
Interval 19.0 to 57.0
|
56 percent lactate clearance
Interval 49.0 to 59.0
|
Adverse Events
Fluid Optimization (FO)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Care (RC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Chris Holthaus
Washington University School of Medicine
Phone: 314-747-5994
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place