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

Shock Clinical Trial

— EFFORT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01128413
• Other study ID #: EFFORT-10-0593
• Status: Terminated
• Phase: N/A
• First received: May 6, 2010
• Last updated: February 6, 2016
• Start date: July 2010
• Est. completion date: November 2013

Study information

• Verified date: February 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Emergencies
• Shock

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital Emergency Department	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (18)

Barbier C, Loubières Y, Schmit C, Hayon J, Ricôme 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. Epub 2004 Mar 18. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Mar 25. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No