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

The Washington University

Status: Terminated

Conditions: Shock

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01128413

EFFORT-10-0593

Details and patient eligibility

About

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).

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Fluid Optimization (FO)

Experimental group

Description:

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.

Treatment:

Biological: Lactate Clearance

Behavioral: CURVES Questionnaire

Device: USCOM ® (Ultrasound Cardiac Output Monitor)

Device: Inferior Vena Cava (IVC) Ultrasound Collapsibility

Biological: 500ml Normal Saline Bolus

Device: Cheetah NICOM® PLRT

Routine Care (RC)

Active Comparator group

Description:

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.

Treatment:

Biological: Lactate Clearance

Biological: Clinician Discretion Intravenous Fluid Management

Behavioral: CURVES Questionnaire

Device: USCOM ® (Ultrasound Cardiac Output Monitor)

Device: Inferior Vena Cava (IVC) Ultrasound Collapsibility

Device: Cheetah NICOM® PLRT