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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01128413
First received: May 6, 2010
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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).


Condition Intervention
Shock
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Lactate Clearance [ Time Frame: The average lactate clearance within 6 hours of the ED stay. ] [ Designated as safety issue: No ]
    The average lactate clearance from time zero to within 6 hours of the ED stay.


Secondary Outcome Measures:
  • ED Volume Responsive Prevalence [ Time Frame: The average of volume responsive prevalence within 6 hours of the ED stay. ] [ Designated as safety issue: No ]
    Within 6 hours of the ED stay, volume responsive prevalence will be determined via Cheetah Reliant NICOM® (Non-Invasive Cardiac Output Monitoring) PLRT (passive leg raise testing). The numerator will be the total number of NICOM® PLRTs with stroke volume index or cardiac index >/= 15% and the denominator will be the total number of NICOM® PLRTs performed.

  • Volume Responsive Correlation-Clinician Estimation [ Time Frame: The average of correlation coefficients within 6 hours of the ED stay. ] [ Designated as safety issue: No ]
    Within 6 hours of the ED stay, the average volume responsiveness as determined by Cheetah Reliant NICOM® passive leg raise testing (stroke volume index or cardiac index change >/= 15%) will be compared with Clinician Estimation (via the "Cardiovascular Response and Volume Estimation in Shock" questionnaire).

  • In-hospital Mortality [ Time Frame: The average death rate occurring within the first 28 days of a consecutive in-patient hospital stay. ] [ Designated as safety issue: Yes ]
    In-hospital mortality: the average death rate occurring within 28 days from the date of hospital admission to the date of expiration, transfer, or discharge from the same hospitalization.

  • Volume Responsive Correlation-USCOM® [ Time Frame: The average of correlation coefficients within 6 hours of the ED stay. ] [ Designated as safety issue: No ]
    Within 6 hours of the ED stay, the average volume responsiveness as determined by Cheetah Reliant NICOM® passive leg raise testing (stroke volume index or cardiac index change >/= 15%) will be compared with Ultrasound Cardiac Output Monitoring (USCOM ®; Uscom Ltd., Sydney, Australia).

  • Volume Responsive Correlation-Inferior Vena Cava Collapsibility [ Time Frame: The average of correlation coefficients within 6 hours of the ED stay. ] [ Designated as safety issue: No ]
    Within 6 hours of the ED stay, the average volume responsiveness as determined by Cheetah Reliant NICOM® passive leg raise testing (stroke volume index or cardiac index change >/= 15%) will be compared with Ultrasound Inferior Vena Cava Collapsibility.


Estimated Enrollment: 125
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluid Optimization (FO)
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.
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.
Active Comparator: Routine Care (RC)
Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion. Results of Cheetah NICOM®PLRT, USCOM®, IVC Ultrasound collapsibility 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
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: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128413

Contacts
Contact: Christopher V Holthaus, MD (314) 747-5994 holthausc@wusm.wustl.edu
Contact: Patricia Suntrup, RT, BA, CCRP (314) 362-7365 suntruppa@wusm.wustl.edu

Locations
United States, Missouri
Barnes-Jewish Hospital Emergency Department Recruiting
St. Louis, Missouri, United States, 63110
Contact: Patricia Suntrup, RT, BA, CCRP    314-362-7365    suntruppa@wusm.wustl.edu   
Sub-Investigator: Brian Wessman, MD         
Sub-Investigator: Tom Ahrens, DNS, CCNS         
Sub-Investigator: Jennifer Williams, MSN, ACNS-BC         
Sub-Investigator: Daniel Theodoro, MD, RDMS         
Sub-Investigator: Richard Hotchkiss, MD         
Sub-Investigator: Enyo Ablordeppey, MD         
Sub-Investigator: Stephanie Charshafian, BS         
Sub-Investigator: Kevin Williams, MD         
Sub-Investigator: Ronald Chang, BA         
Barnes-Jewish Hospital Emergency Department Recruiting
St. Louis, Missouri, United States, 63110
Contact: Patricia Suntrup, RT, BA, CCRP    314-362-7365    suntruppa@wusm.wustl.edu   
Sub-Investigator: Brian Wessman, MD         
Sub-Investigator: Tom Ahrens, DNS, CCNS         
Sub-Investigator: Jennifer Williams, MSN, ACNS-BC         
Sub-Investigator: Daniel Theodoro, MD, RDMS         
Sub-Investigator: Richard Hotchkiss, MD         
Sub-Investigator: Enyo Ablordeppey, MD         
Sub-Investigator: Ronald Chang, BA         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Christopher V Holthaus, MD Washington University Early Recognition Center
Principal Investigator: Brian M Fuller, MD Washington University Early Recognition Center
  More Information

Publications:

Responsible Party: Christopher V. Holthaus, M.D., Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01128413     History of Changes
Other Study ID Numbers: EFFORT-10-0593
Study First Received: May 6, 2010
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Shock
Resuscitation
Hemodynamics
Emergencies
Critical Care
Lactic Acid
Plasma volume

Additional relevant MeSH terms:
Emergencies
Shock
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014