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

NCT01128413 | Terminated Results

• 1 other identifier: EFFORT-10-0593
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Shock; Resuscitation; Hemodynamics; Emergencies; Critical Care; Lactic Acid; Plasma volume

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Fluid Optimization (FO)

EXPERIMENTAL

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; Device: USCOM ® (Ultrasound Cardiac Output Monitor); Device: Inferior Vena Cava (IVC) Ultrasound Collapsibility; Behavioral: CURVES Questionnaire; Biological: Lactate Clearance; Biological: 500ml Normal Saline Bolus

Routine Care (RC)

ACTIVE COMPARATOR

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; Device: USCOM ® (Ultrasound Cardiac Output Monitor); Device: Inferior Vena Cava (IVC) Ultrasound Collapsibility; Behavioral: CURVES Questionnaire; Biological: Lactate Clearance; Biological: Clinician Discretion Intravenous Fluid Management

Interventions

Cheetah NICOM® PLRT DEVICE

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.

Fluid Optimization (FO); Routine Care (RC)

USCOM ® (Ultrasound Cardiac Output Monitor) DEVICE

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.

Fluid Optimization (FO); Routine Care (RC)

Inferior Vena Cava (IVC) Ultrasound Collapsibility DEVICE

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.

Fluid Optimization (FO); Routine Care (RC)

CURVES Questionnaire BEHAVIORAL

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.

Fluid Optimization (FO); Routine Care (RC)

Lactate Clearance BIOLOGICAL

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.

Fluid Optimization (FO); Routine Care (RC)

500ml Normal Saline Bolus BIOLOGICAL

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.

Fluid Optimization (FO)

Clinician Discretion Intravenous Fluid Management BIOLOGICAL

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.

Routine Care (RC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital Emergency Department

St Louis, Missouri, 63110, United States

Location

Related Publications (18)

• Sinert R, Spektor M. Evidence-based emergency medicine/rational clinical examination abstract. Clinical assessment of hypovolemia. Ann Emerg Med. 2005 Mar;45(3):327-9. doi: 10.1016/j.annemergmed.2004.09.021. No abstract available.

  PMID: 15726060 BACKGROUND

• Jones AE, Kline JA. Use of goal-directed therapy for severe sepsis and septic shock in academic emergency departments. Crit Care Med. 2005 Aug;33(8):1888-9; author reply 1889-90. doi: 10.1097/01.ccm.0000166872.78449.b1. No abstract available.

  PMID: 16096485 BACKGROUND

• Blow O, Magliore L, Claridge JA, Butler K, Young JS. The golden hour and the silver day: detection and correction of occult hypoperfusion within 24 hours improves outcome from major trauma. J Trauma. 1999 Nov;47(5):964-9. doi: 10.1097/00005373-199911000-00028.

  PMID: 10568731 BACKGROUND

• Shapiro NI, Howell MD, Talmor D, Nathanson LA, Lisbon A, Wolfe RE, Weiss JW. Serum lactate as a predictor of mortality in emergency department patients with infection. Ann Emerg Med. 2005 May;45(5):524-8. doi: 10.1016/j.annemergmed.2004.12.006.

  PMID: 15855951 BACKGROUND

• Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA, Tomlanovich MC. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 2004 Aug;32(8):1637-42. doi: 10.1097/01.ccm.0000132904.35713.a7.

  PMID: 15286537 BACKGROUND

• Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.

  PMID: 20179283 BACKGROUND

• Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.

  PMID: 9361539 BACKGROUND

• Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

  PMID: 11794169 BACKGROUND

• Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest. 2008 Jul;134(1):172-8. doi: 10.1378/chest.07-2331.

  PMID: 18628220 BACKGROUND

• Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.

  PMID: 19602972 BACKGROUND

• Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.

  PMID: 12065368 BACKGROUND

• Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.

  PMID: 18214429 BACKGROUND

• Thiel SW, Kollef MH, Isakow W. Non-invasive stroke volume measurement and passive leg raising predict volume responsiveness in medical ICU patients: an observational cohort study. Crit Care. 2009;13(4):R111. doi: 10.1186/cc7955. Epub 2009 Jul 8.

  PMID: 19586543 BACKGROUND

• Corley A, Barnett AG, Mullany D, Fraser JF. Nurse-determined assessment of cardiac output. Comparing a non-invasive cardiac output device and pulmonary artery catheter: a prospective observational study. Int J Nurs Stud. 2009 Oct;46(10):1291-7. doi: 10.1016/j.ijnurstu.2009.03.013. Epub 2009 May 6.

  PMID: 19423107 BACKGROUND

• Nguyen HB, Losey T, Rasmussen J, Oliver R, Guptill M, Wittlake WA, Corbett SW. Interrater reliability of cardiac output measurements by transcutaneous Doppler ultrasound: implications for noninvasive hemodynamic monitoring in the ED. Am J Emerg Med. 2006 Nov;24(7):828-35. doi: 10.1016/j.ajem.2006.05.012.

  PMID: 17098106 BACKGROUND

• Barbier C, Loubieres Y, Schmit C, Hayon J, Ricome JL, Jardin F, Vieillard-Baron A. Respiratory changes in inferior vena cava diameter are helpful in predicting fluid responsiveness in ventilated septic patients. Intensive Care Med. 2004 Sep;30(9):1740-6. doi: 10.1007/s00134-004-2259-8. Epub 2004 Mar 18.

  PMID: 15034650 BACKGROUND

• Feissel M, Michard F, Faller JP, Teboul JL. The respiratory variation in inferior vena cava diameter as a guide to fluid therapy. Intensive Care Med. 2004 Sep;30(9):1834-7. doi: 10.1007/s00134-004-2233-5. Epub 2004 Mar 25.

  PMID: 15045170 BACKGROUND

• Perera P, Mailhot T, Riley D, Mandavia D. The RUSH exam: Rapid Ultrasound in SHock in the evaluation of the critically lll. Emerg Med Clin North Am. 2010 Feb;28(1):29-56, vii. doi: 10.1016/j.emc.2009.09.010.

  PMID: 19945597 BACKGROUND

MeSH Terms

Conditions

Shock; Emergencies

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Limitations and Caveats

Trial terminated early due to lack of resources leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Chris Holthaus
• Organization: Washington University School of Medicine

holthauscv@wustl.edu

314-747-5994

Study Officials

• Christopher V Holthaus, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Brian M Fuller, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 21, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 1, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)