Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT)

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).

Conditions

• Shock

Interventions

DEVICE

Cheetah NICOM® PLRT

Cheetah NICOM® (non-invasive cardiac output monitoring)PLRT (passive leg raise testing) protocol: The patient while in a semi-recumbent position (legs level, torso up 45 degrees) will have 3 minutes of stroke volume and cardiac index monitoring. Following the 3 minutes, the patient will be placed in a leg raised position (torso level, legs up 45 degrees) for 3 minutes of stroke volume and cardiac index monitoring. NICOM® PLRT will be performed within 10 minutes after any fluid bolus in both arms with results blinded to the Routine Care arm. If saline locked or maintenance IV fluid rate, NICOM® PLRT will be performed every 30 minutes in both arms with results blinded to the Routine Care arm.

DEVICE

USCOM ® (Ultrasound Cardiac Output Monitor)

Patients while in the Cheetah NICOM® PLRT semi-recumbent position (legs level, torso up 45 degrees) will have simultaneous USCOM® stroke volume and cardiac index monitoring. Following the 3 minutes of Cheetah NICOM® PLRT semi-recumbent positioning, the patient will be placed in a leg raised position (torso level, legs up 45 degrees) and have simultaneous USCOM® stroke volume and cardiac index monitoring. USCOM® monitoring will be blinded to the Routine Care arm unless used as part of a provider's routine practice. USCOM® changes in SVI or CI with PLRT will be calculated after the patient leaves the ED.

DEVICE

Inferior Vena Cava (IVC) Ultrasound Collapsibility

Patients while in the Cheetah NICOM® PLRT semi-recumbent position (legs level, torso up 45 degrees) will have a simultaneous 6-12 second ultrasound recording of their IVC. These recordings will be reviewed later by an ultrasonographer and graded for volume responsiveness. The reviewing ultrasonographer will be blinded to the Cheetah NICOM® PLRT results.

BEHAVIORAL

CURVES Questionnaire

The CURVES (CardiovascUlar Response \& Volume Estimation in Shock) Questionnaire consists of multiple provider questions aimed at defining the presumed shock etiology and anticipated responses to interventions. This will be administered to both arms.

BIOLOGICAL

Lactate Clearance

Lactate samples will be drawn at time 0, 1, 3, \& 6 hours (or at ED departure if before 6 hours). Time 0 lactate will be revealed to the Routine Care arm and subsequent lactates revealed to the Routine Care arm only if serial lactates are part of the provider's routine practice.

BIOLOGICAL

500ml Normal Saline Bolus

Patients randomized to the experimental arm and having a \>/= 15% change in stroke volume index (SVI) or cardiac index (CI) via Cheetah NICOM®PLRT will be given a 500ml normal saline fluid bolus.

BIOLOGICAL

Clinician Discretion Intravenous Fluid Management

Clinicians caring for patients randomized to the Routine Care arm will within 10 minutes after any fluid bolus be asked to decide via their clinical discretion if they want to re-bolus, saline lock, or place the patient on a maintenance IV fluid rate. If the patient is on a saline lock or maintenance fluid rate, clinicians will be asked every 30 minutes to decide via their clinical discretion to re-bolus, saline lock, or place the patient on a maintenance IV fluid rate.

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Christopher V Holthaus, MD · Washington University School of Medicine

• Brian M Fuller, MD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2013-11-30

Completion

2013-11-30

Countries

• United States

Study Locations