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

Shock Clinical Trial

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

Status Terminated

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Shock

• NCT number: NCT01128413
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Terminated
• Phase: N/A
• Start date: July 2010
• Completion date: November 2013