Clinical trial NCT01128413: Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT)
Official title: Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shock
Keywords: Shock
Resuscitation
Hemodynamics
Emergencies
Critical Care
Lactic Acid
Plasma volume
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lactate Clearance
timeFrame: The median lactate clearance within 6 hours of the ED stay.
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Barnes-Jewish Hospital Emergency Department
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Christopher V Holthaus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Brian M Fuller, MD
role: PRINCIPAL_INVESTIGATOR
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