drugset / Trial / NCT01128413
Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT)
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2010-07
- Primary completion
- 2013-11
- Completion
- 2013-11
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sodium chloride | Unknown | 500 ml | — |
Indications
No indication recorded.