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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Shock

Intervention / Treatment
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* Device: Cheetah NICOM® PLRT
* Device: USCOM ® (Ultrasound Cardiac Output Monitor)
* Device: Inferior Vena Cava (IVC) Ultrasound Collapsibility
* Behavioral: CURVES Questionnaire
* Biological: Lactate Clearance
* Biological: 500ml Normal Saline Bolus
* Biological: Clinician Discretion Intravenous Fluid Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluid Optimization (FO)<br>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. 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. Additionally, USCOM®, IVC Ultrasound collapsibility, CURVES Questionnaire, and repeat lactate measurements will be performed. | Device: Cheetah NICOM® PLRT<br>* 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.<br>Device: USCOM ® (Ultrasound Cardiac Output Monitor)<br>* 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.<br>Device: Inferior Vena Cava (IVC) Ultrasound Collapsibility<br>* 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.<br>Behavioral: CURVES Questionnaire<br>* 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.<br>Biological: Lactate Clearance<br>* 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.<br>Biological: 500ml Normal Saline Bolus<br>* 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.<br>|
| Active Comparator: Routine Care (RC)<br>Patients randomized to receive routine ED care will receive IV fluid administration per the treating clinicians discretion. The Cheetah NICOM®PLRT, USCOM®, IVC Ultrasound collapsibility, and CURVES Questionnaire will be performed and repeat lactate measurements will only be revealed to the routine care arm if they are used as part of the provider's routine care. | Device: Cheetah NICOM® PLRT<br>* 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.<br>Device: USCOM ® (Ultrasound Cardiac Output Monitor)<br>* 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.<br>Device: Inferior Vena Cava (IVC) Ultrasound Collapsibility<br>* 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.<br>Behavioral: CURVES Questionnaire<br>* 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.<br>Biological: Lactate Clearance<br>* 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.<br>Biological: Clinician Discretion Intravenous Fluid Management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate Clearance | The median lactate clearance from time zero to within 6 hours of the ED stay. | The median lactate clearance within 6 hours of the ED stay. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock, Resuscitation, Hemodynamics, Emergencies, Critical Care, Lactic Acid, Plasma volume