Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT)
| Status: | Terminated |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2010 |
| End Date: | November 2013 |
The short term goal of this study is to evaluate a non-invasive approach that optimizes
intravenous (IV) fluid administration according to heart performance and results in
surrogate improvements in morbidity and mortality via lactate clearance. Additional
objectives include comparative assessments of methods for determining volume responsiveness
and establishing a prevalence of volume responsive shock in the Emergency Department (ED).
intravenous (IV) fluid administration according to heart performance and results in
surrogate improvements in morbidity and mortality via lactate clearance. Additional
objectives include comparative assessments of methods for determining volume responsiveness
and establishing a prevalence of volume responsive shock in the Emergency Department (ED).
Patients will be randomized to Routine Care (RC) or Fluid Optimizations (FO) arms. Both arms
will have interval Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise
Testing (PLRT).
In the FO arm, patients having a PLRT demonstrating a >/= 15% change in stroke volume index
(SVI) or cardiac index (CI) patients will receive a 500ml normal saline bolus. If the NICOM®
PLRT shows a SVI or CI <15% patients will receive a saline lock. If bolused, NICOM® PLRT
will be performed within 10 minutes after the bolus with the decision to re-bolus or saline
lock according to repeated NICOM® PLRT measurements. If saline locked, NICOM® PLRT will be
performed every 30 minutes with the decision to re-bolus or saline lock according to
repeated NICOM® PLRT measurements.
In the RC arm, IV fluid administration will be per the treating clinicians discretion. The
Cheetah NICOM®PLRT will be performed before and after each clinician fluid bolus.
Lactate blood samples will be drawn at time zero, 1 hour, 3 hours, 6 hours, and/or ED
departure and compared between arms.
will have interval Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise
Testing (PLRT).
In the FO arm, patients having a PLRT demonstrating a >/= 15% change in stroke volume index
(SVI) or cardiac index (CI) patients will receive a 500ml normal saline bolus. If the NICOM®
PLRT shows a SVI or CI <15% patients will receive a saline lock. If bolused, NICOM® PLRT
will be performed within 10 minutes after the bolus with the decision to re-bolus or saline
lock according to repeated NICOM® PLRT measurements. If saline locked, NICOM® PLRT will be
performed every 30 minutes with the decision to re-bolus or saline lock according to
repeated NICOM® PLRT measurements.
In the RC arm, IV fluid administration will be per the treating clinicians discretion. The
Cheetah NICOM®PLRT will be performed before and after each clinician fluid bolus.
Lactate blood samples will be drawn at time zero, 1 hour, 3 hours, 6 hours, and/or ED
departure and compared between arms.
Inclusion Criteria:
- Hypotension (Systolic Blood Pressure ≤90mm Hg or Mean Arterial Pressure ≤ 65 mm Hg)
after ≥ 20ml/kg fluids OR
- Vasopressor Use OR
- Lactate ≥ 2.5 mmol/L
Exclusion Criteria:
- Pulse Oximetry <90% despite supplemental oxygen or intubation
- Seizure in the last 24 hours
- Prisoner
- Pregnancy
- Age <18
- Allergy to coupling or ultrasound gel
- Inability to do passive leg raise
- Inability to obtain IV access
- Treating clinician discretion
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